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AVAHO Implores VA Secretary Collins to Use Caution Amid Rapid Changes
The Association of VA Hematology/Oncology outlined its concerns over “unintended consequences” to recent changes at the US Department of Veterans Affairs (VA) in a March 3, 2025, letter to Secretary Doug A. Collins. “Indiscriminate cuts to contracts and personnel could have unforeseen consequences in many research areas within the VA, so we implore scrutiny,” the letter warns.
“We have already seen specific examples this past week of swift contract cuts impairing the VA’s ability to implement research protocols, process and report pharmacogenomic results, management of Electronic Health Record Modernization (EHRM) council workgroups, and execute new oncology services through the Close to Me initiative,” AVAHO Executive Director Julie Lawson said.
As Lawson noted, the return-to-office order for the staff of the Clinical Resource Hubs (CRHs) and the National Tele-Oncology programs could significantly impair their ability to function. Both departments have been fully remote since their start and are key elements of VA care for rural veterans. In fiscal year 2024, > 500,000 veterans received > 1.4 million CRH encounters. Nearly 20,000 veterans have utilized the National Tele-Oncology program in > 80,000 cancer-care encounters.
“We have significant concern that a blanket return to office of these fully remote programs, without an adequate plan for office space, teleworking equipment, and clinical and administrative support could have significant disruption and impairment in their delivery of care, negatively impacting veteran outcomes,” Lawson said.
AVAHO also strongly urged Collins to continue VA investment in clinical trials specifically and research in general: "To implement and execute research, there must be an adequte system in place to support these research programs."
The Association of VA Hematology/Oncology outlined its concerns over “unintended consequences” to recent changes at the US Department of Veterans Affairs (VA) in a March 3, 2025, letter to Secretary Doug A. Collins. “Indiscriminate cuts to contracts and personnel could have unforeseen consequences in many research areas within the VA, so we implore scrutiny,” the letter warns.
“We have already seen specific examples this past week of swift contract cuts impairing the VA’s ability to implement research protocols, process and report pharmacogenomic results, management of Electronic Health Record Modernization (EHRM) council workgroups, and execute new oncology services through the Close to Me initiative,” AVAHO Executive Director Julie Lawson said.
As Lawson noted, the return-to-office order for the staff of the Clinical Resource Hubs (CRHs) and the National Tele-Oncology programs could significantly impair their ability to function. Both departments have been fully remote since their start and are key elements of VA care for rural veterans. In fiscal year 2024, > 500,000 veterans received > 1.4 million CRH encounters. Nearly 20,000 veterans have utilized the National Tele-Oncology program in > 80,000 cancer-care encounters.
“We have significant concern that a blanket return to office of these fully remote programs, without an adequate plan for office space, teleworking equipment, and clinical and administrative support could have significant disruption and impairment in their delivery of care, negatively impacting veteran outcomes,” Lawson said.
AVAHO also strongly urged Collins to continue VA investment in clinical trials specifically and research in general: "To implement and execute research, there must be an adequte system in place to support these research programs."
The Association of VA Hematology/Oncology outlined its concerns over “unintended consequences” to recent changes at the US Department of Veterans Affairs (VA) in a March 3, 2025, letter to Secretary Doug A. Collins. “Indiscriminate cuts to contracts and personnel could have unforeseen consequences in many research areas within the VA, so we implore scrutiny,” the letter warns.
“We have already seen specific examples this past week of swift contract cuts impairing the VA’s ability to implement research protocols, process and report pharmacogenomic results, management of Electronic Health Record Modernization (EHRM) council workgroups, and execute new oncology services through the Close to Me initiative,” AVAHO Executive Director Julie Lawson said.
As Lawson noted, the return-to-office order for the staff of the Clinical Resource Hubs (CRHs) and the National Tele-Oncology programs could significantly impair their ability to function. Both departments have been fully remote since their start and are key elements of VA care for rural veterans. In fiscal year 2024, > 500,000 veterans received > 1.4 million CRH encounters. Nearly 20,000 veterans have utilized the National Tele-Oncology program in > 80,000 cancer-care encounters.
“We have significant concern that a blanket return to office of these fully remote programs, without an adequate plan for office space, teleworking equipment, and clinical and administrative support could have significant disruption and impairment in their delivery of care, negatively impacting veteran outcomes,” Lawson said.
AVAHO also strongly urged Collins to continue VA investment in clinical trials specifically and research in general: "To implement and execute research, there must be an adequte system in place to support these research programs."
New IL-7 Antagonist Lusvertikimab Shows UC Efficacy
BERLIN —
Lusvertikimab is unique in targeting the IL-7 receptor, a key player in immune-mediated inflammation.
“We have a new mode of action in ulcerative colitis,” with a strong safety profile, lead investigator, Arnaud Bourreille, MD, associate professor of gastroenterology from Nantes University Hospital, France, said in an interview.
“We achieved the primary endpoint” — improvement in the modified Mayo score (MMS) from baseline to week 10 — “for both the low dose and the high dose of lusvertikimab,” said Bourreille, who presented the findings at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress. “For us practitioners, this is very good news.”
Current treatment options for UC remain limited, especially for patients with an inadequate response to biologics or small molecules.
Overall, biologics are only effective in around half the patients, Bourreille noted. We need other treatments that have different mechanisms of action, as is the case with lusvertikimab.
The multicenter, double-blind CoTikiS study evaluated the IL-7 receptor antagonist in 136 adults with moderately to severely active UC (MMS, 4-9) and inadequate response to conventional therapies and/or failure to advanced therapies. Around 40% of the patients were exposed to one or more biologics.
The 50-week study had a 10-week induction period with two doses of lusvertikimab (450 and 850 mg), followed by a 24-week open-label extension, where patients received infusions of the high dose (850 mg) every 4 weeks, and a 16-week safety follow-up period free of treatment.
For the induction period, patients were randomized 1:1:1 to receive placebo (n = 49), 450 mg lusvertikimab (n = 35), or 850 mg lusvertikimab (n = 50) intravenously at weeks 0, 2, and 6. The diagnosis in two patients was modified to Crohn’s disease; therefore, they were not included.
In meeting the trial’s primary endpoint, lusvertikimab significantly reduced disease severity, compared with placebo, at week 10 in both dose groups separately and when pooled.
The MMS in the 450-mg group showed a difference of –1.16 points vs placebo (P = .019), whereas in the 850-mg group, the MMS showed a difference of –0.9 points vs placebo (P = .036). In the pooled group, the difference was –1.00 points vs placebo (P = .010).
The secondary endpoints of clinical remission and endoscopic remission also favored lusvertikimab for the pooled doses vs placebo, at 16% vs 4% (odds ratio [OR], 4.25; P = .066) and 25% vs 13% (OR, 2.33; P = .120), respectively.
For the other secondary endpoints, 32% achieved endoscopic improvement in the pooled group vs 13% in the placebo group (OR, 3.29; P = .027), and the mean score change in the UC Endoscopic Index of Severity was –1.35 for the pooled group vs –0.32 for the placebo group (P = .007).
Fecal calprotectin was reduced by 830 μg/g in the 450-mg group (P =.009), by 635 μg/g in the 850-mg group (P = .018), and 716 μg/g in the pooled group. It was increased by 189 μg/g in the placebo group (P = .004).
No safety concerns were reported.
Bourreille noted that there was a little more lymphopenia in patients on lusvertikimab vs placebo, which is explained by the drug’s mechanism of action. However, “it was transient lymphopenia, without any infection and without any need to interrupt the treatment.”
Next, Bourreille said, we need to demonstrate the efficacy and the safety of the drug in the long term.
“There may be a place for lusvertikimab in patients with Crohn’s disease because the mechanism of action of IL-7 receptor antagonist would potentially have good efficacy in that disease too,” he added.
Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, Greece, who comoderated the session, pointed out that the results supported further clinical development of lusvertikimab.
“As elevated mucosal IL-7/IL-7 [receptor] expression predicts refractoriness to currently used biologic therapies, it would be very interesting to see the potential of lusvertikimab as a treatment for patients who were exposed to advanced therapy or as part of combination therapeutics,” he said.
The study was funded by OSE Immunotherapeutics. Bourreille received funding from OSE Immunotherapeutics; grants from Takeda and Mauna Kea Technologies; and personal fees from AbbVie, Celltrion, Ferring, Galapagos, Gilead, MSD, Medtronic, OSE Immunotherapeutics, Janssen, Pfizer, Roche, Takeda, Tillotts, and Vifor Pharma. Bamias reported receiving grants from Takeda, AbbVie, Mylan/Viatris/Biocon, Genesis Pharma, Ferring, Vianex, and Aenorasis and personal fees/honoraria as adviser/lecturer from AbbVie, Adacyte Therapeutics, Amgen, Bristol Myers Squibb, Ferring, Galenica, Genesis Pharma, Johnson & Johnson, Eli Lilly, MSD, Mylan/Viatris/Biocon, Pfizer, Takeda, and Vianex.
A version of this article appeared on Medscape.com.
BERLIN —
Lusvertikimab is unique in targeting the IL-7 receptor, a key player in immune-mediated inflammation.
“We have a new mode of action in ulcerative colitis,” with a strong safety profile, lead investigator, Arnaud Bourreille, MD, associate professor of gastroenterology from Nantes University Hospital, France, said in an interview.
“We achieved the primary endpoint” — improvement in the modified Mayo score (MMS) from baseline to week 10 — “for both the low dose and the high dose of lusvertikimab,” said Bourreille, who presented the findings at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress. “For us practitioners, this is very good news.”
Current treatment options for UC remain limited, especially for patients with an inadequate response to biologics or small molecules.
Overall, biologics are only effective in around half the patients, Bourreille noted. We need other treatments that have different mechanisms of action, as is the case with lusvertikimab.
The multicenter, double-blind CoTikiS study evaluated the IL-7 receptor antagonist in 136 adults with moderately to severely active UC (MMS, 4-9) and inadequate response to conventional therapies and/or failure to advanced therapies. Around 40% of the patients were exposed to one or more biologics.
The 50-week study had a 10-week induction period with two doses of lusvertikimab (450 and 850 mg), followed by a 24-week open-label extension, where patients received infusions of the high dose (850 mg) every 4 weeks, and a 16-week safety follow-up period free of treatment.
For the induction period, patients were randomized 1:1:1 to receive placebo (n = 49), 450 mg lusvertikimab (n = 35), or 850 mg lusvertikimab (n = 50) intravenously at weeks 0, 2, and 6. The diagnosis in two patients was modified to Crohn’s disease; therefore, they were not included.
In meeting the trial’s primary endpoint, lusvertikimab significantly reduced disease severity, compared with placebo, at week 10 in both dose groups separately and when pooled.
The MMS in the 450-mg group showed a difference of –1.16 points vs placebo (P = .019), whereas in the 850-mg group, the MMS showed a difference of –0.9 points vs placebo (P = .036). In the pooled group, the difference was –1.00 points vs placebo (P = .010).
The secondary endpoints of clinical remission and endoscopic remission also favored lusvertikimab for the pooled doses vs placebo, at 16% vs 4% (odds ratio [OR], 4.25; P = .066) and 25% vs 13% (OR, 2.33; P = .120), respectively.
For the other secondary endpoints, 32% achieved endoscopic improvement in the pooled group vs 13% in the placebo group (OR, 3.29; P = .027), and the mean score change in the UC Endoscopic Index of Severity was –1.35 for the pooled group vs –0.32 for the placebo group (P = .007).
Fecal calprotectin was reduced by 830 μg/g in the 450-mg group (P =.009), by 635 μg/g in the 850-mg group (P = .018), and 716 μg/g in the pooled group. It was increased by 189 μg/g in the placebo group (P = .004).
No safety concerns were reported.
Bourreille noted that there was a little more lymphopenia in patients on lusvertikimab vs placebo, which is explained by the drug’s mechanism of action. However, “it was transient lymphopenia, without any infection and without any need to interrupt the treatment.”
Next, Bourreille said, we need to demonstrate the efficacy and the safety of the drug in the long term.
“There may be a place for lusvertikimab in patients with Crohn’s disease because the mechanism of action of IL-7 receptor antagonist would potentially have good efficacy in that disease too,” he added.
Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, Greece, who comoderated the session, pointed out that the results supported further clinical development of lusvertikimab.
“As elevated mucosal IL-7/IL-7 [receptor] expression predicts refractoriness to currently used biologic therapies, it would be very interesting to see the potential of lusvertikimab as a treatment for patients who were exposed to advanced therapy or as part of combination therapeutics,” he said.
The study was funded by OSE Immunotherapeutics. Bourreille received funding from OSE Immunotherapeutics; grants from Takeda and Mauna Kea Technologies; and personal fees from AbbVie, Celltrion, Ferring, Galapagos, Gilead, MSD, Medtronic, OSE Immunotherapeutics, Janssen, Pfizer, Roche, Takeda, Tillotts, and Vifor Pharma. Bamias reported receiving grants from Takeda, AbbVie, Mylan/Viatris/Biocon, Genesis Pharma, Ferring, Vianex, and Aenorasis and personal fees/honoraria as adviser/lecturer from AbbVie, Adacyte Therapeutics, Amgen, Bristol Myers Squibb, Ferring, Galenica, Genesis Pharma, Johnson & Johnson, Eli Lilly, MSD, Mylan/Viatris/Biocon, Pfizer, Takeda, and Vianex.
A version of this article appeared on Medscape.com.
BERLIN —
Lusvertikimab is unique in targeting the IL-7 receptor, a key player in immune-mediated inflammation.
“We have a new mode of action in ulcerative colitis,” with a strong safety profile, lead investigator, Arnaud Bourreille, MD, associate professor of gastroenterology from Nantes University Hospital, France, said in an interview.
“We achieved the primary endpoint” — improvement in the modified Mayo score (MMS) from baseline to week 10 — “for both the low dose and the high dose of lusvertikimab,” said Bourreille, who presented the findings at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress. “For us practitioners, this is very good news.”
Current treatment options for UC remain limited, especially for patients with an inadequate response to biologics or small molecules.
Overall, biologics are only effective in around half the patients, Bourreille noted. We need other treatments that have different mechanisms of action, as is the case with lusvertikimab.
The multicenter, double-blind CoTikiS study evaluated the IL-7 receptor antagonist in 136 adults with moderately to severely active UC (MMS, 4-9) and inadequate response to conventional therapies and/or failure to advanced therapies. Around 40% of the patients were exposed to one or more biologics.
The 50-week study had a 10-week induction period with two doses of lusvertikimab (450 and 850 mg), followed by a 24-week open-label extension, where patients received infusions of the high dose (850 mg) every 4 weeks, and a 16-week safety follow-up period free of treatment.
For the induction period, patients were randomized 1:1:1 to receive placebo (n = 49), 450 mg lusvertikimab (n = 35), or 850 mg lusvertikimab (n = 50) intravenously at weeks 0, 2, and 6. The diagnosis in two patients was modified to Crohn’s disease; therefore, they were not included.
In meeting the trial’s primary endpoint, lusvertikimab significantly reduced disease severity, compared with placebo, at week 10 in both dose groups separately and when pooled.
The MMS in the 450-mg group showed a difference of –1.16 points vs placebo (P = .019), whereas in the 850-mg group, the MMS showed a difference of –0.9 points vs placebo (P = .036). In the pooled group, the difference was –1.00 points vs placebo (P = .010).
The secondary endpoints of clinical remission and endoscopic remission also favored lusvertikimab for the pooled doses vs placebo, at 16% vs 4% (odds ratio [OR], 4.25; P = .066) and 25% vs 13% (OR, 2.33; P = .120), respectively.
For the other secondary endpoints, 32% achieved endoscopic improvement in the pooled group vs 13% in the placebo group (OR, 3.29; P = .027), and the mean score change in the UC Endoscopic Index of Severity was –1.35 for the pooled group vs –0.32 for the placebo group (P = .007).
Fecal calprotectin was reduced by 830 μg/g in the 450-mg group (P =.009), by 635 μg/g in the 850-mg group (P = .018), and 716 μg/g in the pooled group. It was increased by 189 μg/g in the placebo group (P = .004).
No safety concerns were reported.
Bourreille noted that there was a little more lymphopenia in patients on lusvertikimab vs placebo, which is explained by the drug’s mechanism of action. However, “it was transient lymphopenia, without any infection and without any need to interrupt the treatment.”
Next, Bourreille said, we need to demonstrate the efficacy and the safety of the drug in the long term.
“There may be a place for lusvertikimab in patients with Crohn’s disease because the mechanism of action of IL-7 receptor antagonist would potentially have good efficacy in that disease too,” he added.
Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, Greece, who comoderated the session, pointed out that the results supported further clinical development of lusvertikimab.
“As elevated mucosal IL-7/IL-7 [receptor] expression predicts refractoriness to currently used biologic therapies, it would be very interesting to see the potential of lusvertikimab as a treatment for patients who were exposed to advanced therapy or as part of combination therapeutics,” he said.
The study was funded by OSE Immunotherapeutics. Bourreille received funding from OSE Immunotherapeutics; grants from Takeda and Mauna Kea Technologies; and personal fees from AbbVie, Celltrion, Ferring, Galapagos, Gilead, MSD, Medtronic, OSE Immunotherapeutics, Janssen, Pfizer, Roche, Takeda, Tillotts, and Vifor Pharma. Bamias reported receiving grants from Takeda, AbbVie, Mylan/Viatris/Biocon, Genesis Pharma, Ferring, Vianex, and Aenorasis and personal fees/honoraria as adviser/lecturer from AbbVie, Adacyte Therapeutics, Amgen, Bristol Myers Squibb, Ferring, Galenica, Genesis Pharma, Johnson & Johnson, Eli Lilly, MSD, Mylan/Viatris/Biocon, Pfizer, Takeda, and Vianex.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Virtual Chromoendoscopy Beats Other Modalities at Neoplasia Detection in IBD
BERLIN —
The research, presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress, also found “significant variability in IBD surveillance practice in the real world,” said study presenter Chandni Radia, MD, Department of Gastroenterology, King’s College Hospital NHS Foundation Trust, London, England.
Although dye chromoendoscopy with targeted biopsies traditionally was considered the gold standard for neoplasia detection in patients with IBD, randomized trials have challenged its superiority over virtual chromoendoscopy and high-definition white-light endoscopy, the researchers noted. They hypothesized that the modality used would not affect the neoplasia detection rate.
To investigate, they conducted a retrospective observational cohort study of adults with ulcerative colitis, Crohn’s disease or primary sclerosing cholangitis (PSC) who underwent routine clinical IBD surveillance at one of five centers in the United Kingdom between 2019 and 2023. They examined data from the endoscopy reporting software, alongside endoscopy reports, endoscopy images, and electronic patient records.
In all, 2673 colonoscopies performed on 2050 patients were included, with 1032 procedures using dye chromoendoscopy, 366 using virtual chromoendoscopy, and 1275 using high-definition white-light endoscopy.
The overall neoplasia detection rate was 11.4%, “which is very similar to what has previously been seen in the literature,” Radia said.
However, the detection rate varied significantly by procedure: 19% in virtual chromoendoscopy, 12% in dye chromoendoscopy, and 9% in white-light endoscopy (P < .001). After accounting for a range of potential confounding factors, virtual chromoendoscopy still had the highest neoplasia detection rate.
Dye chromoendoscopy had a “prolonged withdrawal time and increased need for targeted biopsies without improving their neoplasia yield, which goes against our aspirations of sustainability,” Radia noted.
“It was interesting to see that the procedures with the most dye chromoendoscopy seem to have the longest withdrawal time, and those with the most white-light endoscopy seem to have the shortest,” she said. The difference remained significant even after controlling for procedures with polypectomy, “which has a significantly longer withdrawal time compared to procedures without.”
Results Varied by Center
There was wide variability between the five centers on several findings. The neoplasia detection rate ranged from 7.4% to 17.2%, depending on the center.
The surveillance method also varied. One center, for example, used white-light endoscopy in 82% of cases and dye chromoendoscopy in the other 18%. At another center, 61% of patients had dye chromoendoscopy, 36% white-light endoscopy, and 3% virtual chromoendoscopy. In a third center, 48% had virtual chromoendoscopy, 46% white-light endoscopy, and 6% dye chromoendoscopy.
The centers had varying proportions of patients with each of the three conditions, with ulcerative colitis ranging from 46% to 63%, Crohn’s disease from 9% to 39%, and PSC from 14% to 45%.
The heterogeneity of patients between the modality groups is one of the study’s limitations, Radia said. Others are the shorter withdrawal time with white-light endoscopy and the lack of standardized withdrawal time for the procedures.
The research team’s analyses are ongoing and include examination of the types of neoplasia detected, as well as accounting for endoscopist experience and patients who underwent two procedures with different modalities, Radia said.
Reflection of ‘Real-Life Practice’
Because the study was a retrospective analysis, it contains inherent biases and other issues, Raf Bisschops, MD, PhD, director of endoscopy, University of Leuven, Belgium, who co-chaired the session, said in an interview.
However, it was a “thorough analysis” that reflects “real-life practice,” he said. As such, it lends “huge support” to virtual chromoendoscopy, which “actually goes against the new [British Society of Gastroenterology] guideline that is about to come out.” The society plans to recommend in favor of dye chromoendoscopy, but the new study findings could be still incorporated into the upcoming guidelines so as to also endorse virtual chromoendoscopy.
Whatever the modality used, clinicians need to make sure they “pay attention” when looking for small neoplastic lesions, and “anything that can help you do that, that draws your attention to cell lesions ... can be helpful,” Bisschops said.
Performing targeted biopsies, as with dye chromoendoscopy, can be problematic, as “people don’t pay attention anymore to those cell lesions; they just focus on taking the 32 biopsies, which is a huge endeavor and it’s a pain to do it,” he added.
Radia has received a Research Training Fellowship Award from the UK patient organization PSC Support. No other funding was declared. Radia declared relationships with Abbvie, Galapogos, and Dr. Falk Pharma.
A version of this article appeared on Medscape.com.
BERLIN —
The research, presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress, also found “significant variability in IBD surveillance practice in the real world,” said study presenter Chandni Radia, MD, Department of Gastroenterology, King’s College Hospital NHS Foundation Trust, London, England.
Although dye chromoendoscopy with targeted biopsies traditionally was considered the gold standard for neoplasia detection in patients with IBD, randomized trials have challenged its superiority over virtual chromoendoscopy and high-definition white-light endoscopy, the researchers noted. They hypothesized that the modality used would not affect the neoplasia detection rate.
To investigate, they conducted a retrospective observational cohort study of adults with ulcerative colitis, Crohn’s disease or primary sclerosing cholangitis (PSC) who underwent routine clinical IBD surveillance at one of five centers in the United Kingdom between 2019 and 2023. They examined data from the endoscopy reporting software, alongside endoscopy reports, endoscopy images, and electronic patient records.
In all, 2673 colonoscopies performed on 2050 patients were included, with 1032 procedures using dye chromoendoscopy, 366 using virtual chromoendoscopy, and 1275 using high-definition white-light endoscopy.
The overall neoplasia detection rate was 11.4%, “which is very similar to what has previously been seen in the literature,” Radia said.
However, the detection rate varied significantly by procedure: 19% in virtual chromoendoscopy, 12% in dye chromoendoscopy, and 9% in white-light endoscopy (P < .001). After accounting for a range of potential confounding factors, virtual chromoendoscopy still had the highest neoplasia detection rate.
Dye chromoendoscopy had a “prolonged withdrawal time and increased need for targeted biopsies without improving their neoplasia yield, which goes against our aspirations of sustainability,” Radia noted.
“It was interesting to see that the procedures with the most dye chromoendoscopy seem to have the longest withdrawal time, and those with the most white-light endoscopy seem to have the shortest,” she said. The difference remained significant even after controlling for procedures with polypectomy, “which has a significantly longer withdrawal time compared to procedures without.”
Results Varied by Center
There was wide variability between the five centers on several findings. The neoplasia detection rate ranged from 7.4% to 17.2%, depending on the center.
The surveillance method also varied. One center, for example, used white-light endoscopy in 82% of cases and dye chromoendoscopy in the other 18%. At another center, 61% of patients had dye chromoendoscopy, 36% white-light endoscopy, and 3% virtual chromoendoscopy. In a third center, 48% had virtual chromoendoscopy, 46% white-light endoscopy, and 6% dye chromoendoscopy.
The centers had varying proportions of patients with each of the three conditions, with ulcerative colitis ranging from 46% to 63%, Crohn’s disease from 9% to 39%, and PSC from 14% to 45%.
The heterogeneity of patients between the modality groups is one of the study’s limitations, Radia said. Others are the shorter withdrawal time with white-light endoscopy and the lack of standardized withdrawal time for the procedures.
The research team’s analyses are ongoing and include examination of the types of neoplasia detected, as well as accounting for endoscopist experience and patients who underwent two procedures with different modalities, Radia said.
Reflection of ‘Real-Life Practice’
Because the study was a retrospective analysis, it contains inherent biases and other issues, Raf Bisschops, MD, PhD, director of endoscopy, University of Leuven, Belgium, who co-chaired the session, said in an interview.
However, it was a “thorough analysis” that reflects “real-life practice,” he said. As such, it lends “huge support” to virtual chromoendoscopy, which “actually goes against the new [British Society of Gastroenterology] guideline that is about to come out.” The society plans to recommend in favor of dye chromoendoscopy, but the new study findings could be still incorporated into the upcoming guidelines so as to also endorse virtual chromoendoscopy.
Whatever the modality used, clinicians need to make sure they “pay attention” when looking for small neoplastic lesions, and “anything that can help you do that, that draws your attention to cell lesions ... can be helpful,” Bisschops said.
Performing targeted biopsies, as with dye chromoendoscopy, can be problematic, as “people don’t pay attention anymore to those cell lesions; they just focus on taking the 32 biopsies, which is a huge endeavor and it’s a pain to do it,” he added.
Radia has received a Research Training Fellowship Award from the UK patient organization PSC Support. No other funding was declared. Radia declared relationships with Abbvie, Galapogos, and Dr. Falk Pharma.
A version of this article appeared on Medscape.com.
BERLIN —
The research, presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress, also found “significant variability in IBD surveillance practice in the real world,” said study presenter Chandni Radia, MD, Department of Gastroenterology, King’s College Hospital NHS Foundation Trust, London, England.
Although dye chromoendoscopy with targeted biopsies traditionally was considered the gold standard for neoplasia detection in patients with IBD, randomized trials have challenged its superiority over virtual chromoendoscopy and high-definition white-light endoscopy, the researchers noted. They hypothesized that the modality used would not affect the neoplasia detection rate.
To investigate, they conducted a retrospective observational cohort study of adults with ulcerative colitis, Crohn’s disease or primary sclerosing cholangitis (PSC) who underwent routine clinical IBD surveillance at one of five centers in the United Kingdom between 2019 and 2023. They examined data from the endoscopy reporting software, alongside endoscopy reports, endoscopy images, and electronic patient records.
In all, 2673 colonoscopies performed on 2050 patients were included, with 1032 procedures using dye chromoendoscopy, 366 using virtual chromoendoscopy, and 1275 using high-definition white-light endoscopy.
The overall neoplasia detection rate was 11.4%, “which is very similar to what has previously been seen in the literature,” Radia said.
However, the detection rate varied significantly by procedure: 19% in virtual chromoendoscopy, 12% in dye chromoendoscopy, and 9% in white-light endoscopy (P < .001). After accounting for a range of potential confounding factors, virtual chromoendoscopy still had the highest neoplasia detection rate.
Dye chromoendoscopy had a “prolonged withdrawal time and increased need for targeted biopsies without improving their neoplasia yield, which goes against our aspirations of sustainability,” Radia noted.
“It was interesting to see that the procedures with the most dye chromoendoscopy seem to have the longest withdrawal time, and those with the most white-light endoscopy seem to have the shortest,” she said. The difference remained significant even after controlling for procedures with polypectomy, “which has a significantly longer withdrawal time compared to procedures without.”
Results Varied by Center
There was wide variability between the five centers on several findings. The neoplasia detection rate ranged from 7.4% to 17.2%, depending on the center.
The surveillance method also varied. One center, for example, used white-light endoscopy in 82% of cases and dye chromoendoscopy in the other 18%. At another center, 61% of patients had dye chromoendoscopy, 36% white-light endoscopy, and 3% virtual chromoendoscopy. In a third center, 48% had virtual chromoendoscopy, 46% white-light endoscopy, and 6% dye chromoendoscopy.
The centers had varying proportions of patients with each of the three conditions, with ulcerative colitis ranging from 46% to 63%, Crohn’s disease from 9% to 39%, and PSC from 14% to 45%.
The heterogeneity of patients between the modality groups is one of the study’s limitations, Radia said. Others are the shorter withdrawal time with white-light endoscopy and the lack of standardized withdrawal time for the procedures.
The research team’s analyses are ongoing and include examination of the types of neoplasia detected, as well as accounting for endoscopist experience and patients who underwent two procedures with different modalities, Radia said.
Reflection of ‘Real-Life Practice’
Because the study was a retrospective analysis, it contains inherent biases and other issues, Raf Bisschops, MD, PhD, director of endoscopy, University of Leuven, Belgium, who co-chaired the session, said in an interview.
However, it was a “thorough analysis” that reflects “real-life practice,” he said. As such, it lends “huge support” to virtual chromoendoscopy, which “actually goes against the new [British Society of Gastroenterology] guideline that is about to come out.” The society plans to recommend in favor of dye chromoendoscopy, but the new study findings could be still incorporated into the upcoming guidelines so as to also endorse virtual chromoendoscopy.
Whatever the modality used, clinicians need to make sure they “pay attention” when looking for small neoplastic lesions, and “anything that can help you do that, that draws your attention to cell lesions ... can be helpful,” Bisschops said.
Performing targeted biopsies, as with dye chromoendoscopy, can be problematic, as “people don’t pay attention anymore to those cell lesions; they just focus on taking the 32 biopsies, which is a huge endeavor and it’s a pain to do it,” he added.
Radia has received a Research Training Fellowship Award from the UK patient organization PSC Support. No other funding was declared. Radia declared relationships with Abbvie, Galapogos, and Dr. Falk Pharma.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
AI Improves Lesion Detection in IBD Over Standard Methods
BERLIN — in a first-of-its-kind, multicenter study.
In addition to the model’s superior diagnostic performance than standard of care, it also achieved a significant reduction in the mean reading time per exam.
Furthermore, the study clinically validated an AI model in real time for small-bowel CE.
The AI model addresses long-standing limitations of CE interpretation, including time-consuming readings and interobserver variability.
“It’s a huge improvement on the technology readiness level of the AI model,” said senior study investigator Miguel Mascarenhas, MD, PhD, head of the precision medicine unit at the Hospital São João, Faculty of Medicine, University of Porto, Portugal.
Until now, there has been no AI system using a CE platform that has proven so effective in so many real-life clinical settings, he explained. “This technology is set to transform endoscopic practice and clinical management in inflammatory bowel disease.”
The findings were presented at European Crohn’s and Colitis Organisation 2025 Congress by Francisco Mendes, MD, a resident in gastroenterology, also at the Hospital São João.
More Lesions, Less Time
Researchers conducted the prospective study involving centers in Portugal, Spain, and the United States between January 2021 and April 2024. Two CE devices (PillCamSB3 and Olympus EC-10) were analyzed for their performance across 137 CE exams in 137 patients, 49 of whom had Crohn’s disease. AI-assisted readings were compared with standard-of-care readings, with expert board consensus considered to be the gold standard. Key performance metrics included sensitivity, specificity, positive predictive value (PPV), and negative PV (NPV).
During expert board review, ulcers and erosions were identified in 56 patients (40.9%), with a sensitivity of 60.7%, specificity of 98.8%, a PPV of 97.1%, and an NPV of 78.4%, leading to an overall accuracy for the detection of ulcers and erosions of 83.2%.
In comparison, the AI-assisted readings outperformed conventional readings with a sensitivity of 94.6%, specificity of 80.2%, a PPV of 76.8%, an NPV of 95.6%, leading to an overall accuracy of 86.1%.
The AI-assisted model diagnosis was noninferior (P < .001) and superior (P < .001) to conventional diagnosis for detection of ulcers and erosions. The AI model demonstrated consistent performance across different CE devices and centers.
In addition, the mean time taken per reading was under 4 minutes (239 seconds) per exam for AI, compared with around 1.0-1.5 hours for standard-of-care readings.
The increased diagnostic accuracy of this AI model done in far less time allows us to engage more with the patient and attend to other care-related tasks, Mascarenhas said.
CE has great potential not only in IBD but also in other gastrointestinal-related screening, including colorectal cancer screening, he added. Once the bottleneck of reading time with CE is solved, it will become the first-line tool for screening.
Reading time is “one of several barriers” to integration of CE into clinical practice, Shomron Ben-Horin, MD, director, Sheba Medical Center, Tel-Aviv University, Israel, said in an interview. But it “is the most accurate modality for detection of inflammatory activity along the entire small bowel.”
Based on these study results, AI is the way to go, said Ben-Horin, who was not involved in the study. “There was even a signal for better accuracy, which is intriguing,” he added. This study points toward AI being more accurate than the physicians in reading, and that is important.
Also commenting was Miles Parkes, MD, consultant gastroenterologist at Addenbrooke’s Hospital in Cambridge, England.
“Both the sensitivity and the specificity of the output are reassuring, but there might be some devil in the detail,” he said. “However, as a general principle the performance of this model is impressive.”
Mascarenhas and Mendes declared no financial disclosures. Ben Horin received fees from Medtronic to attend the conference. Parkes declared no financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — in a first-of-its-kind, multicenter study.
In addition to the model’s superior diagnostic performance than standard of care, it also achieved a significant reduction in the mean reading time per exam.
Furthermore, the study clinically validated an AI model in real time for small-bowel CE.
The AI model addresses long-standing limitations of CE interpretation, including time-consuming readings and interobserver variability.
“It’s a huge improvement on the technology readiness level of the AI model,” said senior study investigator Miguel Mascarenhas, MD, PhD, head of the precision medicine unit at the Hospital São João, Faculty of Medicine, University of Porto, Portugal.
Until now, there has been no AI system using a CE platform that has proven so effective in so many real-life clinical settings, he explained. “This technology is set to transform endoscopic practice and clinical management in inflammatory bowel disease.”
The findings were presented at European Crohn’s and Colitis Organisation 2025 Congress by Francisco Mendes, MD, a resident in gastroenterology, also at the Hospital São João.
More Lesions, Less Time
Researchers conducted the prospective study involving centers in Portugal, Spain, and the United States between January 2021 and April 2024. Two CE devices (PillCamSB3 and Olympus EC-10) were analyzed for their performance across 137 CE exams in 137 patients, 49 of whom had Crohn’s disease. AI-assisted readings were compared with standard-of-care readings, with expert board consensus considered to be the gold standard. Key performance metrics included sensitivity, specificity, positive predictive value (PPV), and negative PV (NPV).
During expert board review, ulcers and erosions were identified in 56 patients (40.9%), with a sensitivity of 60.7%, specificity of 98.8%, a PPV of 97.1%, and an NPV of 78.4%, leading to an overall accuracy for the detection of ulcers and erosions of 83.2%.
In comparison, the AI-assisted readings outperformed conventional readings with a sensitivity of 94.6%, specificity of 80.2%, a PPV of 76.8%, an NPV of 95.6%, leading to an overall accuracy of 86.1%.
The AI-assisted model diagnosis was noninferior (P < .001) and superior (P < .001) to conventional diagnosis for detection of ulcers and erosions. The AI model demonstrated consistent performance across different CE devices and centers.
In addition, the mean time taken per reading was under 4 minutes (239 seconds) per exam for AI, compared with around 1.0-1.5 hours for standard-of-care readings.
The increased diagnostic accuracy of this AI model done in far less time allows us to engage more with the patient and attend to other care-related tasks, Mascarenhas said.
CE has great potential not only in IBD but also in other gastrointestinal-related screening, including colorectal cancer screening, he added. Once the bottleneck of reading time with CE is solved, it will become the first-line tool for screening.
Reading time is “one of several barriers” to integration of CE into clinical practice, Shomron Ben-Horin, MD, director, Sheba Medical Center, Tel-Aviv University, Israel, said in an interview. But it “is the most accurate modality for detection of inflammatory activity along the entire small bowel.”
Based on these study results, AI is the way to go, said Ben-Horin, who was not involved in the study. “There was even a signal for better accuracy, which is intriguing,” he added. This study points toward AI being more accurate than the physicians in reading, and that is important.
Also commenting was Miles Parkes, MD, consultant gastroenterologist at Addenbrooke’s Hospital in Cambridge, England.
“Both the sensitivity and the specificity of the output are reassuring, but there might be some devil in the detail,” he said. “However, as a general principle the performance of this model is impressive.”
Mascarenhas and Mendes declared no financial disclosures. Ben Horin received fees from Medtronic to attend the conference. Parkes declared no financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — in a first-of-its-kind, multicenter study.
In addition to the model’s superior diagnostic performance than standard of care, it also achieved a significant reduction in the mean reading time per exam.
Furthermore, the study clinically validated an AI model in real time for small-bowel CE.
The AI model addresses long-standing limitations of CE interpretation, including time-consuming readings and interobserver variability.
“It’s a huge improvement on the technology readiness level of the AI model,” said senior study investigator Miguel Mascarenhas, MD, PhD, head of the precision medicine unit at the Hospital São João, Faculty of Medicine, University of Porto, Portugal.
Until now, there has been no AI system using a CE platform that has proven so effective in so many real-life clinical settings, he explained. “This technology is set to transform endoscopic practice and clinical management in inflammatory bowel disease.”
The findings were presented at European Crohn’s and Colitis Organisation 2025 Congress by Francisco Mendes, MD, a resident in gastroenterology, also at the Hospital São João.
More Lesions, Less Time
Researchers conducted the prospective study involving centers in Portugal, Spain, and the United States between January 2021 and April 2024. Two CE devices (PillCamSB3 and Olympus EC-10) were analyzed for their performance across 137 CE exams in 137 patients, 49 of whom had Crohn’s disease. AI-assisted readings were compared with standard-of-care readings, with expert board consensus considered to be the gold standard. Key performance metrics included sensitivity, specificity, positive predictive value (PPV), and negative PV (NPV).
During expert board review, ulcers and erosions were identified in 56 patients (40.9%), with a sensitivity of 60.7%, specificity of 98.8%, a PPV of 97.1%, and an NPV of 78.4%, leading to an overall accuracy for the detection of ulcers and erosions of 83.2%.
In comparison, the AI-assisted readings outperformed conventional readings with a sensitivity of 94.6%, specificity of 80.2%, a PPV of 76.8%, an NPV of 95.6%, leading to an overall accuracy of 86.1%.
The AI-assisted model diagnosis was noninferior (P < .001) and superior (P < .001) to conventional diagnosis for detection of ulcers and erosions. The AI model demonstrated consistent performance across different CE devices and centers.
In addition, the mean time taken per reading was under 4 minutes (239 seconds) per exam for AI, compared with around 1.0-1.5 hours for standard-of-care readings.
The increased diagnostic accuracy of this AI model done in far less time allows us to engage more with the patient and attend to other care-related tasks, Mascarenhas said.
CE has great potential not only in IBD but also in other gastrointestinal-related screening, including colorectal cancer screening, he added. Once the bottleneck of reading time with CE is solved, it will become the first-line tool for screening.
Reading time is “one of several barriers” to integration of CE into clinical practice, Shomron Ben-Horin, MD, director, Sheba Medical Center, Tel-Aviv University, Israel, said in an interview. But it “is the most accurate modality for detection of inflammatory activity along the entire small bowel.”
Based on these study results, AI is the way to go, said Ben-Horin, who was not involved in the study. “There was even a signal for better accuracy, which is intriguing,” he added. This study points toward AI being more accurate than the physicians in reading, and that is important.
Also commenting was Miles Parkes, MD, consultant gastroenterologist at Addenbrooke’s Hospital in Cambridge, England.
“Both the sensitivity and the specificity of the output are reassuring, but there might be some devil in the detail,” he said. “However, as a general principle the performance of this model is impressive.”
Mascarenhas and Mendes declared no financial disclosures. Ben Horin received fees from Medtronic to attend the conference. Parkes declared no financial disclosures.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Antibody Profiles Predict IBD Up To 10 Years Before Onset
BERLIN — a new study suggested.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“High-throughput and high-resolution antibody profiling delineates a previously underappreciated landscape of selective serological responses in inflammatory bowel disease,” said study presenter Arno R. Bourgonje, MD, PhD, of the Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City.
The discovery represents just the “tip of the iceberg” in terms of understanding how antibody response could predict IBD onset, he added. Although validation studies are ongoing, the findings “allow for novel insights into disease pathogenesis and also for allowing for disease prediction.”
In IBD, the integrity of the intestinal barrier is compromised and luminal agents, like bacteria, can leak through, which leads to immune activation, Bourgonje said.
However, only a few serological antibody responses are known to occur in IBD, such as antibodies against the yeast Saccharomyces cerevisiae and those against the cytoplasm of neutrophils, he said.
But most antibody responses are directed against bacteria, Bourgonje noted. The gut microbiome represents thousands of different bacterial species, each of which encode for thousands of different genes, representing a tremendous number of potential antigens. But conventional antibody-profiling technologies weren’t powerful enough to identify antibodies in patients with IBD that signal an immune response to potential antigens in the gut.
To get at that problem, the researchers recently leveraged a high-throughput technology called phage-display immunoprecipitation sequencing (PhIP-Seq) to look for specific immune-based biomarker signatures in the blood of individuals with IBD. This effort revealed a distinct repertoire of antibodies not only against bacteria but also against viruses and cell antigens.
The researchers next turned their sights on discovering whether they could find evidence of immunological alterations before IBD onset to enable disease prediction.
Predictive Signatures Found
The team used a longitudinal preclinical IBD cohort called PREDICTS (Proteomic Evaluation and Discovery in an IBD Cohort of Tri-service Subjects) that is housed in the US Department of Defense Serum Repository.
Using PhIP-Seq, the researchers analyzed serum samples from 200 individuals who developed Crohn’s disease, 200 who developed ulcerative colitis, and 100 non-IBD controls matched for age, sex, race, and study time point. The samples were collected approximately 2 years, 4 years, and 10 years prior to diagnosis as well around the time of diagnosis.
The results showed that, compared with healthy controls, the diversity of the antibody repertoire was significantly lower in the sera of individuals with preclinical Crohn’s disease (P < .05) and ulcerative colitis (P < .001), with the lowest similarity seen in people with preclinical Crohn’s disease approximately 4 years prior to their diagnosis (P < .001).
The study also found that, compared with healthy controls, antibody responses in individuals with preclinical Crohn’s disease against herpes viruses such as Epstein-Barr virus (EBV), cytomegalovirus (CMV), and herpes simplex virus (HSV)–1 and HSV-2 were significantly higher approximately 10 years prior to the diagnosis of Crohn’s disease, whereas anti-Streptococcus responses were lower.
In individuals with ulcerative colitis, antibody responses to EBV, CMV, HSV-1, and influenza viruses were significantly higher than that in healthy controls approximately 10 years prior to diagnosis, whereas anti-rhinovirus responses were lower.
Further analysis demonstrated that antibody responses to CMV and EBV proteins increased over the course of the preclinical phase of Crohn’s disease vs healthy controls (P = .008 and P = .011, respectively).
Similarly, autoantibody responses to MAP kinase–activating death domain increased during the preclinical phase of ulcerative colitis vs healthy controls (P = .0025), whereas anti-Streptococcus responses decreased (P = .005).
Interestingly, no one single antibody response difference with healthy controls was able to accurately predict the onset of IBD 10 years prior to diagnosis, but distinct sets of antibody responses were, with area under the receiver operating characteristic curve of 0.90 for Crohn’s disease and 0.84 for ulcerative colitis.
A Promising Start
The study has potential to be useful for identifying people at risk for IBD, Robin Dart, MD, PhD, a consultant gastroenterologist at Guy’s and St Thomas Hospital, London, England, who co-chaired the session, said in an interview.
The difference in antibody responses to viral and bacterial antigens between Crohn’s disease and ulcerative colitis could point toward underlying biological mechanisms, although it is “too early to say,” Dart said.
However, “when you do these kind of big fishing exercises” and identify microbes may be implicated in IBD, “you end up finding more questions than answers,” although that “can only be a good thing,” he added.
Bourgonje noted that the study cohort consisted entirely of men enrolled in the US Army, limiting the applicability of the findings. Another limitation was that researchers were unable to control smoking, antibiotic use, and diet, all of which could have affected the results.
This study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Bourgonje declared relationships with Janssen Pharmaceuticals, Ferring, AbbVie. Other authors also declared numerous relationships.
A version of this article appeared on Medscape.com.
BERLIN — a new study suggested.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“High-throughput and high-resolution antibody profiling delineates a previously underappreciated landscape of selective serological responses in inflammatory bowel disease,” said study presenter Arno R. Bourgonje, MD, PhD, of the Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City.
The discovery represents just the “tip of the iceberg” in terms of understanding how antibody response could predict IBD onset, he added. Although validation studies are ongoing, the findings “allow for novel insights into disease pathogenesis and also for allowing for disease prediction.”
In IBD, the integrity of the intestinal barrier is compromised and luminal agents, like bacteria, can leak through, which leads to immune activation, Bourgonje said.
However, only a few serological antibody responses are known to occur in IBD, such as antibodies against the yeast Saccharomyces cerevisiae and those against the cytoplasm of neutrophils, he said.
But most antibody responses are directed against bacteria, Bourgonje noted. The gut microbiome represents thousands of different bacterial species, each of which encode for thousands of different genes, representing a tremendous number of potential antigens. But conventional antibody-profiling technologies weren’t powerful enough to identify antibodies in patients with IBD that signal an immune response to potential antigens in the gut.
To get at that problem, the researchers recently leveraged a high-throughput technology called phage-display immunoprecipitation sequencing (PhIP-Seq) to look for specific immune-based biomarker signatures in the blood of individuals with IBD. This effort revealed a distinct repertoire of antibodies not only against bacteria but also against viruses and cell antigens.
The researchers next turned their sights on discovering whether they could find evidence of immunological alterations before IBD onset to enable disease prediction.
Predictive Signatures Found
The team used a longitudinal preclinical IBD cohort called PREDICTS (Proteomic Evaluation and Discovery in an IBD Cohort of Tri-service Subjects) that is housed in the US Department of Defense Serum Repository.
Using PhIP-Seq, the researchers analyzed serum samples from 200 individuals who developed Crohn’s disease, 200 who developed ulcerative colitis, and 100 non-IBD controls matched for age, sex, race, and study time point. The samples were collected approximately 2 years, 4 years, and 10 years prior to diagnosis as well around the time of diagnosis.
The results showed that, compared with healthy controls, the diversity of the antibody repertoire was significantly lower in the sera of individuals with preclinical Crohn’s disease (P < .05) and ulcerative colitis (P < .001), with the lowest similarity seen in people with preclinical Crohn’s disease approximately 4 years prior to their diagnosis (P < .001).
The study also found that, compared with healthy controls, antibody responses in individuals with preclinical Crohn’s disease against herpes viruses such as Epstein-Barr virus (EBV), cytomegalovirus (CMV), and herpes simplex virus (HSV)–1 and HSV-2 were significantly higher approximately 10 years prior to the diagnosis of Crohn’s disease, whereas anti-Streptococcus responses were lower.
In individuals with ulcerative colitis, antibody responses to EBV, CMV, HSV-1, and influenza viruses were significantly higher than that in healthy controls approximately 10 years prior to diagnosis, whereas anti-rhinovirus responses were lower.
Further analysis demonstrated that antibody responses to CMV and EBV proteins increased over the course of the preclinical phase of Crohn’s disease vs healthy controls (P = .008 and P = .011, respectively).
Similarly, autoantibody responses to MAP kinase–activating death domain increased during the preclinical phase of ulcerative colitis vs healthy controls (P = .0025), whereas anti-Streptococcus responses decreased (P = .005).
Interestingly, no one single antibody response difference with healthy controls was able to accurately predict the onset of IBD 10 years prior to diagnosis, but distinct sets of antibody responses were, with area under the receiver operating characteristic curve of 0.90 for Crohn’s disease and 0.84 for ulcerative colitis.
A Promising Start
The study has potential to be useful for identifying people at risk for IBD, Robin Dart, MD, PhD, a consultant gastroenterologist at Guy’s and St Thomas Hospital, London, England, who co-chaired the session, said in an interview.
The difference in antibody responses to viral and bacterial antigens between Crohn’s disease and ulcerative colitis could point toward underlying biological mechanisms, although it is “too early to say,” Dart said.
However, “when you do these kind of big fishing exercises” and identify microbes may be implicated in IBD, “you end up finding more questions than answers,” although that “can only be a good thing,” he added.
Bourgonje noted that the study cohort consisted entirely of men enrolled in the US Army, limiting the applicability of the findings. Another limitation was that researchers were unable to control smoking, antibiotic use, and diet, all of which could have affected the results.
This study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Bourgonje declared relationships with Janssen Pharmaceuticals, Ferring, AbbVie. Other authors also declared numerous relationships.
A version of this article appeared on Medscape.com.
BERLIN — a new study suggested.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“High-throughput and high-resolution antibody profiling delineates a previously underappreciated landscape of selective serological responses in inflammatory bowel disease,” said study presenter Arno R. Bourgonje, MD, PhD, of the Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City.
The discovery represents just the “tip of the iceberg” in terms of understanding how antibody response could predict IBD onset, he added. Although validation studies are ongoing, the findings “allow for novel insights into disease pathogenesis and also for allowing for disease prediction.”
In IBD, the integrity of the intestinal barrier is compromised and luminal agents, like bacteria, can leak through, which leads to immune activation, Bourgonje said.
However, only a few serological antibody responses are known to occur in IBD, such as antibodies against the yeast Saccharomyces cerevisiae and those against the cytoplasm of neutrophils, he said.
But most antibody responses are directed against bacteria, Bourgonje noted. The gut microbiome represents thousands of different bacterial species, each of which encode for thousands of different genes, representing a tremendous number of potential antigens. But conventional antibody-profiling technologies weren’t powerful enough to identify antibodies in patients with IBD that signal an immune response to potential antigens in the gut.
To get at that problem, the researchers recently leveraged a high-throughput technology called phage-display immunoprecipitation sequencing (PhIP-Seq) to look for specific immune-based biomarker signatures in the blood of individuals with IBD. This effort revealed a distinct repertoire of antibodies not only against bacteria but also against viruses and cell antigens.
The researchers next turned their sights on discovering whether they could find evidence of immunological alterations before IBD onset to enable disease prediction.
Predictive Signatures Found
The team used a longitudinal preclinical IBD cohort called PREDICTS (Proteomic Evaluation and Discovery in an IBD Cohort of Tri-service Subjects) that is housed in the US Department of Defense Serum Repository.
Using PhIP-Seq, the researchers analyzed serum samples from 200 individuals who developed Crohn’s disease, 200 who developed ulcerative colitis, and 100 non-IBD controls matched for age, sex, race, and study time point. The samples were collected approximately 2 years, 4 years, and 10 years prior to diagnosis as well around the time of diagnosis.
The results showed that, compared with healthy controls, the diversity of the antibody repertoire was significantly lower in the sera of individuals with preclinical Crohn’s disease (P < .05) and ulcerative colitis (P < .001), with the lowest similarity seen in people with preclinical Crohn’s disease approximately 4 years prior to their diagnosis (P < .001).
The study also found that, compared with healthy controls, antibody responses in individuals with preclinical Crohn’s disease against herpes viruses such as Epstein-Barr virus (EBV), cytomegalovirus (CMV), and herpes simplex virus (HSV)–1 and HSV-2 were significantly higher approximately 10 years prior to the diagnosis of Crohn’s disease, whereas anti-Streptococcus responses were lower.
In individuals with ulcerative colitis, antibody responses to EBV, CMV, HSV-1, and influenza viruses were significantly higher than that in healthy controls approximately 10 years prior to diagnosis, whereas anti-rhinovirus responses were lower.
Further analysis demonstrated that antibody responses to CMV and EBV proteins increased over the course of the preclinical phase of Crohn’s disease vs healthy controls (P = .008 and P = .011, respectively).
Similarly, autoantibody responses to MAP kinase–activating death domain increased during the preclinical phase of ulcerative colitis vs healthy controls (P = .0025), whereas anti-Streptococcus responses decreased (P = .005).
Interestingly, no one single antibody response difference with healthy controls was able to accurately predict the onset of IBD 10 years prior to diagnosis, but distinct sets of antibody responses were, with area under the receiver operating characteristic curve of 0.90 for Crohn’s disease and 0.84 for ulcerative colitis.
A Promising Start
The study has potential to be useful for identifying people at risk for IBD, Robin Dart, MD, PhD, a consultant gastroenterologist at Guy’s and St Thomas Hospital, London, England, who co-chaired the session, said in an interview.
The difference in antibody responses to viral and bacterial antigens between Crohn’s disease and ulcerative colitis could point toward underlying biological mechanisms, although it is “too early to say,” Dart said.
However, “when you do these kind of big fishing exercises” and identify microbes may be implicated in IBD, “you end up finding more questions than answers,” although that “can only be a good thing,” he added.
Bourgonje noted that the study cohort consisted entirely of men enrolled in the US Army, limiting the applicability of the findings. Another limitation was that researchers were unable to control smoking, antibiotic use, and diet, all of which could have affected the results.
This study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Bourgonje declared relationships with Janssen Pharmaceuticals, Ferring, AbbVie. Other authors also declared numerous relationships.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Last Month in Oncology: FDA Cancer News Roundup
Last month, the United States Food and Drug Administration (FDA) approved two new drugs and two biosimilars as well as halted commercialization for a hemophilia treatment.
Here’s a deeper look of what happened last month.
New Drugs
1. The FDA has approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.) for adult and pediatric patients 2 years or older with neurofibromatosis type 1 and symptomatic plexiform neurofibromas that are not amenable to complete resection.
Approval for this agent was based on overall response rate findings from a multicenter, single-arm, phase 2b trial. The trial, which enrolled 58 adults and 56 pediatric patients with this rare disease, reported confirmed overall response rates of 41% among adults and 52% among children.
Adverse reactions occurring in at least 25% of adults included rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. Mirdametinib can also cause ocular toxicity. Treatment should be withheld, discontinued, or the dosage reduced based on the severity of these adverse reactions, according to the FDA notice.
2. The FDA has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult patients with symptomatic tenosynovial giant cell tumors who will not benefit from surgical resection.
Vimseltinib was approved based on findings from the MOTION trial, which included 123 patients randomly assigned 2:1 to vimseltinib 30 mg twice weekly or to placebo for 24 weeks. At 25 weeks, the objective response rate was 40% in the vimseltinib arm and 0% in the placebo arm. The median duration of response was not reached in the vimseltinib arm. Patients receiving vimseltinib also demonstrated significant improvements in active range of motion, physical functioning, and pain at this time. After another 6 months of follow-up, 58% of responders had a duration of response of 9 months or longer.
Treatment-emergent adverse events in MOTION were largely of grade 1 or 2. The most common adverse reactions, occurring in at least 20% of patients, included increased aspartate aminotransferase, periorbital edema, fatigue, rash, and cholesterol.
New or Expanded Indications
1. The FDA has approved a supplemental Biologics License Application for brentuximab vedotin (Adcetris, Seagen Inc.), in combination with lenalidomide and rituximab, for adults with relapsed or refractory large B-cell lymphoma, after at least two prior lines of therapy, who are ineligible for stem cell transplant or chimeric antigen receptor T-cell therapy. This includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma.
Approval was based on the randomized, double-blind, placebo-controlled ECHELON-3 trial, which randomly assigned patients 1:1 to receive lenalidomide and rituximab plus either brentuximab vedotin or placebo until disease progression or unacceptable toxicity. Researchers reported a median overall survival of 13.8 months in the treatment group vs 8.5 months in the placebo group (hazard ratio, 0.63).
2. The FDA has approved the Biologics License Application for Ospomyv and Xbryk (Samsung Bioepis Co.) — biosimilars referencing denosumab (Prolia and Xgeva, respectively) — to treat osteoporosis and cancer-related bone loss.
Ospomyv and Xbryk have been approved for use in all indications of the approved reference drugs. Specifically, Xbryk is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma, and Ospomyv is indicated in several populations of patients with osteoporosis at high risk for fracture.
“The FDA approval of Ospomyv and Xbryk marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the United States,” Byoungin Jung, vice president at Samsung Bioepis, said in the news release.
Drug Commercialization Halt
Pfizer announced last month that it will halt the global development and commercialization of its hemophilia gene therapy fidanacogene elaparvovec (Beqvez). The company cited several reasons for the discontinuation, including low demand from patients and doctors.
Beqvez is a one-time therapy approved in the United States last April to treat adults with moderate to severe hemophilia B, a rare bleeding disorder that affects almost 4 in 100,000 men in the United States.
The significant price tag is one reason hematologists have cited for the low uptake. Another barrier is that “we don’t know the long-term outcomes” associated with the drug, pediatric hematologist Ben Samelson-Jones, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania and Children’s Hospital of Philadelphia, Philadelphia, told this news organization earlier this year.
Other issues include the prospect of newer treatment advances in the hemophilia space and logistical challenges. “There’s just a lot of logistics to getting an institution ready to provide this type of therapy,” Samelson-Jones added.
A version of this article first appeared on Medscape.com.
Last month, the United States Food and Drug Administration (FDA) approved two new drugs and two biosimilars as well as halted commercialization for a hemophilia treatment.
Here’s a deeper look of what happened last month.
New Drugs
1. The FDA has approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.) for adult and pediatric patients 2 years or older with neurofibromatosis type 1 and symptomatic plexiform neurofibromas that are not amenable to complete resection.
Approval for this agent was based on overall response rate findings from a multicenter, single-arm, phase 2b trial. The trial, which enrolled 58 adults and 56 pediatric patients with this rare disease, reported confirmed overall response rates of 41% among adults and 52% among children.
Adverse reactions occurring in at least 25% of adults included rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. Mirdametinib can also cause ocular toxicity. Treatment should be withheld, discontinued, or the dosage reduced based on the severity of these adverse reactions, according to the FDA notice.
2. The FDA has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult patients with symptomatic tenosynovial giant cell tumors who will not benefit from surgical resection.
Vimseltinib was approved based on findings from the MOTION trial, which included 123 patients randomly assigned 2:1 to vimseltinib 30 mg twice weekly or to placebo for 24 weeks. At 25 weeks, the objective response rate was 40% in the vimseltinib arm and 0% in the placebo arm. The median duration of response was not reached in the vimseltinib arm. Patients receiving vimseltinib also demonstrated significant improvements in active range of motion, physical functioning, and pain at this time. After another 6 months of follow-up, 58% of responders had a duration of response of 9 months or longer.
Treatment-emergent adverse events in MOTION were largely of grade 1 or 2. The most common adverse reactions, occurring in at least 20% of patients, included increased aspartate aminotransferase, periorbital edema, fatigue, rash, and cholesterol.
New or Expanded Indications
1. The FDA has approved a supplemental Biologics License Application for brentuximab vedotin (Adcetris, Seagen Inc.), in combination with lenalidomide and rituximab, for adults with relapsed or refractory large B-cell lymphoma, after at least two prior lines of therapy, who are ineligible for stem cell transplant or chimeric antigen receptor T-cell therapy. This includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma.
Approval was based on the randomized, double-blind, placebo-controlled ECHELON-3 trial, which randomly assigned patients 1:1 to receive lenalidomide and rituximab plus either brentuximab vedotin or placebo until disease progression or unacceptable toxicity. Researchers reported a median overall survival of 13.8 months in the treatment group vs 8.5 months in the placebo group (hazard ratio, 0.63).
2. The FDA has approved the Biologics License Application for Ospomyv and Xbryk (Samsung Bioepis Co.) — biosimilars referencing denosumab (Prolia and Xgeva, respectively) — to treat osteoporosis and cancer-related bone loss.
Ospomyv and Xbryk have been approved for use in all indications of the approved reference drugs. Specifically, Xbryk is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma, and Ospomyv is indicated in several populations of patients with osteoporosis at high risk for fracture.
“The FDA approval of Ospomyv and Xbryk marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the United States,” Byoungin Jung, vice president at Samsung Bioepis, said in the news release.
Drug Commercialization Halt
Pfizer announced last month that it will halt the global development and commercialization of its hemophilia gene therapy fidanacogene elaparvovec (Beqvez). The company cited several reasons for the discontinuation, including low demand from patients and doctors.
Beqvez is a one-time therapy approved in the United States last April to treat adults with moderate to severe hemophilia B, a rare bleeding disorder that affects almost 4 in 100,000 men in the United States.
The significant price tag is one reason hematologists have cited for the low uptake. Another barrier is that “we don’t know the long-term outcomes” associated with the drug, pediatric hematologist Ben Samelson-Jones, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania and Children’s Hospital of Philadelphia, Philadelphia, told this news organization earlier this year.
Other issues include the prospect of newer treatment advances in the hemophilia space and logistical challenges. “There’s just a lot of logistics to getting an institution ready to provide this type of therapy,” Samelson-Jones added.
A version of this article first appeared on Medscape.com.
Last month, the United States Food and Drug Administration (FDA) approved two new drugs and two biosimilars as well as halted commercialization for a hemophilia treatment.
Here’s a deeper look of what happened last month.
New Drugs
1. The FDA has approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.) for adult and pediatric patients 2 years or older with neurofibromatosis type 1 and symptomatic plexiform neurofibromas that are not amenable to complete resection.
Approval for this agent was based on overall response rate findings from a multicenter, single-arm, phase 2b trial. The trial, which enrolled 58 adults and 56 pediatric patients with this rare disease, reported confirmed overall response rates of 41% among adults and 52% among children.
Adverse reactions occurring in at least 25% of adults included rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. Mirdametinib can also cause ocular toxicity. Treatment should be withheld, discontinued, or the dosage reduced based on the severity of these adverse reactions, according to the FDA notice.
2. The FDA has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult patients with symptomatic tenosynovial giant cell tumors who will not benefit from surgical resection.
Vimseltinib was approved based on findings from the MOTION trial, which included 123 patients randomly assigned 2:1 to vimseltinib 30 mg twice weekly or to placebo for 24 weeks. At 25 weeks, the objective response rate was 40% in the vimseltinib arm and 0% in the placebo arm. The median duration of response was not reached in the vimseltinib arm. Patients receiving vimseltinib also demonstrated significant improvements in active range of motion, physical functioning, and pain at this time. After another 6 months of follow-up, 58% of responders had a duration of response of 9 months or longer.
Treatment-emergent adverse events in MOTION were largely of grade 1 or 2. The most common adverse reactions, occurring in at least 20% of patients, included increased aspartate aminotransferase, periorbital edema, fatigue, rash, and cholesterol.
New or Expanded Indications
1. The FDA has approved a supplemental Biologics License Application for brentuximab vedotin (Adcetris, Seagen Inc.), in combination with lenalidomide and rituximab, for adults with relapsed or refractory large B-cell lymphoma, after at least two prior lines of therapy, who are ineligible for stem cell transplant or chimeric antigen receptor T-cell therapy. This includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma.
Approval was based on the randomized, double-blind, placebo-controlled ECHELON-3 trial, which randomly assigned patients 1:1 to receive lenalidomide and rituximab plus either brentuximab vedotin or placebo until disease progression or unacceptable toxicity. Researchers reported a median overall survival of 13.8 months in the treatment group vs 8.5 months in the placebo group (hazard ratio, 0.63).
2. The FDA has approved the Biologics License Application for Ospomyv and Xbryk (Samsung Bioepis Co.) — biosimilars referencing denosumab (Prolia and Xgeva, respectively) — to treat osteoporosis and cancer-related bone loss.
Ospomyv and Xbryk have been approved for use in all indications of the approved reference drugs. Specifically, Xbryk is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma, and Ospomyv is indicated in several populations of patients with osteoporosis at high risk for fracture.
“The FDA approval of Ospomyv and Xbryk marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the United States,” Byoungin Jung, vice president at Samsung Bioepis, said in the news release.
Drug Commercialization Halt
Pfizer announced last month that it will halt the global development and commercialization of its hemophilia gene therapy fidanacogene elaparvovec (Beqvez). The company cited several reasons for the discontinuation, including low demand from patients and doctors.
Beqvez is a one-time therapy approved in the United States last April to treat adults with moderate to severe hemophilia B, a rare bleeding disorder that affects almost 4 in 100,000 men in the United States.
The significant price tag is one reason hematologists have cited for the low uptake. Another barrier is that “we don’t know the long-term outcomes” associated with the drug, pediatric hematologist Ben Samelson-Jones, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania and Children’s Hospital of Philadelphia, Philadelphia, told this news organization earlier this year.
Other issues include the prospect of newer treatment advances in the hemophilia space and logistical challenges. “There’s just a lot of logistics to getting an institution ready to provide this type of therapy,” Samelson-Jones added.
A version of this article first appeared on Medscape.com.
New Biomarkers Identified for Treatment Response in IBD
BERLIN — presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Differences uncovered in multiple messenger RNAs, proteins, metabolites, and gut microbiota were associated with responders and nonresponders to biologics and Janus kinase inhibitors, suggesting the potential for predictive biomarkers in IBD, including Crohn’s disease (CD) and ulcerative colitis (UC).
“With further work we hope to confirm these findings and evaluate their clinical relevance in identifying patients most likely to respond to tailored therapeutic interventions,” said Montserrat Baldan-Martin, PhD, a researcher at the University Hospital of the Princess, Madrid, Spain.
The treatment of IBD is challenging because of the heterogeneity across clinical, immunological, molecular, genetic, and microbiologic features, with one third of patients failing to respond to any one treatment.
Baldan-Martin and colleagues wanted to find predictive biomarkers of response by examining the differences across multi-omics profiles relative to different therapies.
The study analyzed 127 patients with IBD (57 with CD and 70 with UC) before and after 14 weeks of treatment with one of the following: anti–tumor necrosis factors (TNFs), ustekinumab, vedolizumab, or tofacitinib. Patient response to treatment was evaluated using endoscopic criteria that categorized them as responders or nonresponders to the different therapies.
In addition, molecular data from various biologic samples — serum, urine, extracellular vesicles, intestinal biopsies, and stool — were tested using transcriptomics, proteomics, metabolomics, and metagenomics.
Clear Differences
“The most significant differences were seen in gene expression within intestinal tissue of responder and nonresponder patients with ulcerative colitis taking vedolizumab,” Baldan-Martin reported.
Proteomic analysis revealed that a total of 1377 proteins were identified across all groups (CD, UC, and the four drug classes/therapies). Responders and nonresponders for each therapy expressed different proteins in serum extracellular vesicles and intestinal tissues.
For example, patients with CD who responded to anti-TNF therapies had 138 different proteins from those of anti-TNF nonresponders, while patients with UC who responded to anti-TNF therapies had 218 different proteins from those of anti-TNF nonresponders, reported Baldan-Martin.
Also, we observed almost no proteins “in common between ulcerative colitis responders versus nonresponders for all treatments,” she noted. And we “saw only three proteins in common with Crohn’s disease patients [on different drugs].”
Metabolomic analysis identified deregulation of 24 serum lipoproteins in CD responders to ustekinumab, compared with nonresponders.
“We observed greater differences in the lipoproteins in serum than metabolites in serum and urine,” Baldan-Martin added.
Analysis of biologic pathways also highlighted enrichment in ketone and butyrate metabolism, mitochondrial electron transport chain activity, carnitine synthesis, and fatty acid oxidation pathways, while metagenomic analysis revealed the greatest microbial differences in UC responders and nonresponders to anti-TNF therapies.
Baldan-Martin said research was ongoing with a new cohort of patients that aims to validate some of the biomarkers and help identify the patients most likely to respond to tailored therapeutic interventions.
“One of the challenges is integrating results from different omics approaches to create a more holistic understanding of the disease,” she said, adding that she hopes the research “will potentially open doors for early detection through multi-panel biomarkers.”
Session moderator Mark Samaan, MD, consultant gastroenterologist at Guy’s and St Thomas’ NHS Foundation Trust, London, England, said that “the findings related to nonresponse to specific drugs in UC and CD were interesting. With longitudinal follow-up, we’d hope this might help us pick out patients less likely to respond and who show early nonresponse to specific drugs based on serum, urine, and fecal sampling.”
“It’s very helpful to know if someone is a nonresponder within 14 weeks because we can then move the patient on to something else relatively quickly,” he added.
Baldan-Martin and Samaan declared no relevant financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Differences uncovered in multiple messenger RNAs, proteins, metabolites, and gut microbiota were associated with responders and nonresponders to biologics and Janus kinase inhibitors, suggesting the potential for predictive biomarkers in IBD, including Crohn’s disease (CD) and ulcerative colitis (UC).
“With further work we hope to confirm these findings and evaluate their clinical relevance in identifying patients most likely to respond to tailored therapeutic interventions,” said Montserrat Baldan-Martin, PhD, a researcher at the University Hospital of the Princess, Madrid, Spain.
The treatment of IBD is challenging because of the heterogeneity across clinical, immunological, molecular, genetic, and microbiologic features, with one third of patients failing to respond to any one treatment.
Baldan-Martin and colleagues wanted to find predictive biomarkers of response by examining the differences across multi-omics profiles relative to different therapies.
The study analyzed 127 patients with IBD (57 with CD and 70 with UC) before and after 14 weeks of treatment with one of the following: anti–tumor necrosis factors (TNFs), ustekinumab, vedolizumab, or tofacitinib. Patient response to treatment was evaluated using endoscopic criteria that categorized them as responders or nonresponders to the different therapies.
In addition, molecular data from various biologic samples — serum, urine, extracellular vesicles, intestinal biopsies, and stool — were tested using transcriptomics, proteomics, metabolomics, and metagenomics.
Clear Differences
“The most significant differences were seen in gene expression within intestinal tissue of responder and nonresponder patients with ulcerative colitis taking vedolizumab,” Baldan-Martin reported.
Proteomic analysis revealed that a total of 1377 proteins were identified across all groups (CD, UC, and the four drug classes/therapies). Responders and nonresponders for each therapy expressed different proteins in serum extracellular vesicles and intestinal tissues.
For example, patients with CD who responded to anti-TNF therapies had 138 different proteins from those of anti-TNF nonresponders, while patients with UC who responded to anti-TNF therapies had 218 different proteins from those of anti-TNF nonresponders, reported Baldan-Martin.
Also, we observed almost no proteins “in common between ulcerative colitis responders versus nonresponders for all treatments,” she noted. And we “saw only three proteins in common with Crohn’s disease patients [on different drugs].”
Metabolomic analysis identified deregulation of 24 serum lipoproteins in CD responders to ustekinumab, compared with nonresponders.
“We observed greater differences in the lipoproteins in serum than metabolites in serum and urine,” Baldan-Martin added.
Analysis of biologic pathways also highlighted enrichment in ketone and butyrate metabolism, mitochondrial electron transport chain activity, carnitine synthesis, and fatty acid oxidation pathways, while metagenomic analysis revealed the greatest microbial differences in UC responders and nonresponders to anti-TNF therapies.
Baldan-Martin said research was ongoing with a new cohort of patients that aims to validate some of the biomarkers and help identify the patients most likely to respond to tailored therapeutic interventions.
“One of the challenges is integrating results from different omics approaches to create a more holistic understanding of the disease,” she said, adding that she hopes the research “will potentially open doors for early detection through multi-panel biomarkers.”
Session moderator Mark Samaan, MD, consultant gastroenterologist at Guy’s and St Thomas’ NHS Foundation Trust, London, England, said that “the findings related to nonresponse to specific drugs in UC and CD were interesting. With longitudinal follow-up, we’d hope this might help us pick out patients less likely to respond and who show early nonresponse to specific drugs based on serum, urine, and fecal sampling.”
“It’s very helpful to know if someone is a nonresponder within 14 weeks because we can then move the patient on to something else relatively quickly,” he added.
Baldan-Martin and Samaan declared no relevant financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Differences uncovered in multiple messenger RNAs, proteins, metabolites, and gut microbiota were associated with responders and nonresponders to biologics and Janus kinase inhibitors, suggesting the potential for predictive biomarkers in IBD, including Crohn’s disease (CD) and ulcerative colitis (UC).
“With further work we hope to confirm these findings and evaluate their clinical relevance in identifying patients most likely to respond to tailored therapeutic interventions,” said Montserrat Baldan-Martin, PhD, a researcher at the University Hospital of the Princess, Madrid, Spain.
The treatment of IBD is challenging because of the heterogeneity across clinical, immunological, molecular, genetic, and microbiologic features, with one third of patients failing to respond to any one treatment.
Baldan-Martin and colleagues wanted to find predictive biomarkers of response by examining the differences across multi-omics profiles relative to different therapies.
The study analyzed 127 patients with IBD (57 with CD and 70 with UC) before and after 14 weeks of treatment with one of the following: anti–tumor necrosis factors (TNFs), ustekinumab, vedolizumab, or tofacitinib. Patient response to treatment was evaluated using endoscopic criteria that categorized them as responders or nonresponders to the different therapies.
In addition, molecular data from various biologic samples — serum, urine, extracellular vesicles, intestinal biopsies, and stool — were tested using transcriptomics, proteomics, metabolomics, and metagenomics.
Clear Differences
“The most significant differences were seen in gene expression within intestinal tissue of responder and nonresponder patients with ulcerative colitis taking vedolizumab,” Baldan-Martin reported.
Proteomic analysis revealed that a total of 1377 proteins were identified across all groups (CD, UC, and the four drug classes/therapies). Responders and nonresponders for each therapy expressed different proteins in serum extracellular vesicles and intestinal tissues.
For example, patients with CD who responded to anti-TNF therapies had 138 different proteins from those of anti-TNF nonresponders, while patients with UC who responded to anti-TNF therapies had 218 different proteins from those of anti-TNF nonresponders, reported Baldan-Martin.
Also, we observed almost no proteins “in common between ulcerative colitis responders versus nonresponders for all treatments,” she noted. And we “saw only three proteins in common with Crohn’s disease patients [on different drugs].”
Metabolomic analysis identified deregulation of 24 serum lipoproteins in CD responders to ustekinumab, compared with nonresponders.
“We observed greater differences in the lipoproteins in serum than metabolites in serum and urine,” Baldan-Martin added.
Analysis of biologic pathways also highlighted enrichment in ketone and butyrate metabolism, mitochondrial electron transport chain activity, carnitine synthesis, and fatty acid oxidation pathways, while metagenomic analysis revealed the greatest microbial differences in UC responders and nonresponders to anti-TNF therapies.
Baldan-Martin said research was ongoing with a new cohort of patients that aims to validate some of the biomarkers and help identify the patients most likely to respond to tailored therapeutic interventions.
“One of the challenges is integrating results from different omics approaches to create a more holistic understanding of the disease,” she said, adding that she hopes the research “will potentially open doors for early detection through multi-panel biomarkers.”
Session moderator Mark Samaan, MD, consultant gastroenterologist at Guy’s and St Thomas’ NHS Foundation Trust, London, England, said that “the findings related to nonresponse to specific drugs in UC and CD were interesting. With longitudinal follow-up, we’d hope this might help us pick out patients less likely to respond and who show early nonresponse to specific drugs based on serum, urine, and fecal sampling.”
“It’s very helpful to know if someone is a nonresponder within 14 weeks because we can then move the patient on to something else relatively quickly,” he added.
Baldan-Martin and Samaan declared no relevant financial disclosures.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Not All Plant-based Diets Are Equal in IBD Risk Mitigation
BERLIN — according to the results of a large cohort study.
The study, which included both Crohn’s disease (CD) and ulcerative colitis (UC), also showed that diet quality may affect disease progression and surgery risk for individuals already diagnosed with IBD.
“Not all plant-based foods are equal — they don’t all have the same effect on health outcomes,” said study researcher, Judith Wellens, MD, PhD, gastroenterology resident at Leuven University Hospital in Belgium.
“We need to look at what people are eating more carefully because it isn’t black and white, with all plant-based food being good and animal-based food being bad,” said Wellens, who presented the data at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Although she advocates for plant-based diets, Wellens stressed that “they need to be individualized to ensure the overall dietary quality is good. Just cutting out meat products is not very helpful. We think it is the unhealthy additions to some plant-based diets that drive the IBD risk.”
Is It the Plants or the Processed Ingredients?
“Preclinical studies have already taught us that plant-based diets alter the gut microbiota in a beneficial way. However, many diets promoted for IBD — for example the Crohn’s disease exclusion diet — contain ingredients that are animal based. This is confusing for patients and for clinicians,” said Wellens.
To look more closely at the question, she and her colleagues analyzed data for 187,888 participants from the UK Biobank and 341,539 participants from across eight European countries from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. None of the participants had IBD at baseline.
Based on participant 24-hour dietary recalls, the researchers constructed plant-based diet indices (PDIs) with diets categorized as healthy (eg, whole grains, fruits, vegetables, legumes, and vegetarian protein alternatives) or unhealthy (eg, emulsifiers, refined grains, fries, fruit juices, sweets, desserts, sugar-sweetened beverages, and processed foods).
The primary outcome was the incidence of IBD (either CD or UC), whereas the secondary outcome was IBD-related surgery, thereby marking disease progression. Cox regression analysis estimated IBD risk and progression. Incidences of IBD were similar between the two cohorts.
In the UK Biobank cohort, 925 participants developed IBD over a median follow-up of 11.6 years. Participants who followed a healthy PDI had a 25% reduced IBD risk, whereas those who followed an unhealthy PDI had a 48% increased risk for disease development. Both CD and UC showed similar outcomes.
The EPIC cohort had a longer median follow-up time of 14.5 years, during which 548 people developed IBD. Healthy PDIs were linked to a 29% reduced risk for IBD, whereas unhealthy PDIs were associated with a 54% increased risk.
A healthy PDI halved the risk for surgery in participants from the UK Biobank, whereas an unhealthy PDI was associated with a twofold higher risk for surgery.
There were no significant associations between PDIs and other outcomes, such as cardiovascular disease, diabetes, or all-cause mortality.
The researchers also looked at the interactions between genetics and plant-based diets, but those results were not presented at the meeting.
However, Wellens said in an interview that people with a moderate to high risk for IBD based on their polygenetic risk score showed increased odds for IBD risk.
“We don’t test people for their genetic risk of IBD, but if people have close relatives with IBD, then there is probably an increased genetic risk of its development,” she added.
Commenting on the findings, James Lindsay, PhD, professor of inflammatory bowel disease, Queen Mary University of London in England, said that several recent epidemiological studies have highlighted “the negative impact of ultra-processed foods on increasing the risk of developing Crohn’s disease.”
Based on these studies, “one might assume that plant-based diets would be protective,” he said, however, the current study shows us “that plant-based diets are not all equal and there are unhealthy aspects to some.”
“Of course, showing that a diet is associated with an outcome is not the same as knowing that changing a diet will reduce the risk,” Lindsay added. “That requires a well-designed, carefully controlled trial.”
Wellens and Lindsay reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — according to the results of a large cohort study.
The study, which included both Crohn’s disease (CD) and ulcerative colitis (UC), also showed that diet quality may affect disease progression and surgery risk for individuals already diagnosed with IBD.
“Not all plant-based foods are equal — they don’t all have the same effect on health outcomes,” said study researcher, Judith Wellens, MD, PhD, gastroenterology resident at Leuven University Hospital in Belgium.
“We need to look at what people are eating more carefully because it isn’t black and white, with all plant-based food being good and animal-based food being bad,” said Wellens, who presented the data at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Although she advocates for plant-based diets, Wellens stressed that “they need to be individualized to ensure the overall dietary quality is good. Just cutting out meat products is not very helpful. We think it is the unhealthy additions to some plant-based diets that drive the IBD risk.”
Is It the Plants or the Processed Ingredients?
“Preclinical studies have already taught us that plant-based diets alter the gut microbiota in a beneficial way. However, many diets promoted for IBD — for example the Crohn’s disease exclusion diet — contain ingredients that are animal based. This is confusing for patients and for clinicians,” said Wellens.
To look more closely at the question, she and her colleagues analyzed data for 187,888 participants from the UK Biobank and 341,539 participants from across eight European countries from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. None of the participants had IBD at baseline.
Based on participant 24-hour dietary recalls, the researchers constructed plant-based diet indices (PDIs) with diets categorized as healthy (eg, whole grains, fruits, vegetables, legumes, and vegetarian protein alternatives) or unhealthy (eg, emulsifiers, refined grains, fries, fruit juices, sweets, desserts, sugar-sweetened beverages, and processed foods).
The primary outcome was the incidence of IBD (either CD or UC), whereas the secondary outcome was IBD-related surgery, thereby marking disease progression. Cox regression analysis estimated IBD risk and progression. Incidences of IBD were similar between the two cohorts.
In the UK Biobank cohort, 925 participants developed IBD over a median follow-up of 11.6 years. Participants who followed a healthy PDI had a 25% reduced IBD risk, whereas those who followed an unhealthy PDI had a 48% increased risk for disease development. Both CD and UC showed similar outcomes.
The EPIC cohort had a longer median follow-up time of 14.5 years, during which 548 people developed IBD. Healthy PDIs were linked to a 29% reduced risk for IBD, whereas unhealthy PDIs were associated with a 54% increased risk.
A healthy PDI halved the risk for surgery in participants from the UK Biobank, whereas an unhealthy PDI was associated with a twofold higher risk for surgery.
There were no significant associations between PDIs and other outcomes, such as cardiovascular disease, diabetes, or all-cause mortality.
The researchers also looked at the interactions between genetics and plant-based diets, but those results were not presented at the meeting.
However, Wellens said in an interview that people with a moderate to high risk for IBD based on their polygenetic risk score showed increased odds for IBD risk.
“We don’t test people for their genetic risk of IBD, but if people have close relatives with IBD, then there is probably an increased genetic risk of its development,” she added.
Commenting on the findings, James Lindsay, PhD, professor of inflammatory bowel disease, Queen Mary University of London in England, said that several recent epidemiological studies have highlighted “the negative impact of ultra-processed foods on increasing the risk of developing Crohn’s disease.”
Based on these studies, “one might assume that plant-based diets would be protective,” he said, however, the current study shows us “that plant-based diets are not all equal and there are unhealthy aspects to some.”
“Of course, showing that a diet is associated with an outcome is not the same as knowing that changing a diet will reduce the risk,” Lindsay added. “That requires a well-designed, carefully controlled trial.”
Wellens and Lindsay reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
BERLIN — according to the results of a large cohort study.
The study, which included both Crohn’s disease (CD) and ulcerative colitis (UC), also showed that diet quality may affect disease progression and surgery risk for individuals already diagnosed with IBD.
“Not all plant-based foods are equal — they don’t all have the same effect on health outcomes,” said study researcher, Judith Wellens, MD, PhD, gastroenterology resident at Leuven University Hospital in Belgium.
“We need to look at what people are eating more carefully because it isn’t black and white, with all plant-based food being good and animal-based food being bad,” said Wellens, who presented the data at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Although she advocates for plant-based diets, Wellens stressed that “they need to be individualized to ensure the overall dietary quality is good. Just cutting out meat products is not very helpful. We think it is the unhealthy additions to some plant-based diets that drive the IBD risk.”
Is It the Plants or the Processed Ingredients?
“Preclinical studies have already taught us that plant-based diets alter the gut microbiota in a beneficial way. However, many diets promoted for IBD — for example the Crohn’s disease exclusion diet — contain ingredients that are animal based. This is confusing for patients and for clinicians,” said Wellens.
To look more closely at the question, she and her colleagues analyzed data for 187,888 participants from the UK Biobank and 341,539 participants from across eight European countries from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. None of the participants had IBD at baseline.
Based on participant 24-hour dietary recalls, the researchers constructed plant-based diet indices (PDIs) with diets categorized as healthy (eg, whole grains, fruits, vegetables, legumes, and vegetarian protein alternatives) or unhealthy (eg, emulsifiers, refined grains, fries, fruit juices, sweets, desserts, sugar-sweetened beverages, and processed foods).
The primary outcome was the incidence of IBD (either CD or UC), whereas the secondary outcome was IBD-related surgery, thereby marking disease progression. Cox regression analysis estimated IBD risk and progression. Incidences of IBD were similar between the two cohorts.
In the UK Biobank cohort, 925 participants developed IBD over a median follow-up of 11.6 years. Participants who followed a healthy PDI had a 25% reduced IBD risk, whereas those who followed an unhealthy PDI had a 48% increased risk for disease development. Both CD and UC showed similar outcomes.
The EPIC cohort had a longer median follow-up time of 14.5 years, during which 548 people developed IBD. Healthy PDIs were linked to a 29% reduced risk for IBD, whereas unhealthy PDIs were associated with a 54% increased risk.
A healthy PDI halved the risk for surgery in participants from the UK Biobank, whereas an unhealthy PDI was associated with a twofold higher risk for surgery.
There were no significant associations between PDIs and other outcomes, such as cardiovascular disease, diabetes, or all-cause mortality.
The researchers also looked at the interactions between genetics and plant-based diets, but those results were not presented at the meeting.
However, Wellens said in an interview that people with a moderate to high risk for IBD based on their polygenetic risk score showed increased odds for IBD risk.
“We don’t test people for their genetic risk of IBD, but if people have close relatives with IBD, then there is probably an increased genetic risk of its development,” she added.
Commenting on the findings, James Lindsay, PhD, professor of inflammatory bowel disease, Queen Mary University of London in England, said that several recent epidemiological studies have highlighted “the negative impact of ultra-processed foods on increasing the risk of developing Crohn’s disease.”
Based on these studies, “one might assume that plant-based diets would be protective,” he said, however, the current study shows us “that plant-based diets are not all equal and there are unhealthy aspects to some.”
“Of course, showing that a diet is associated with an outcome is not the same as knowing that changing a diet will reduce the risk,” Lindsay added. “That requires a well-designed, carefully controlled trial.”
Wellens and Lindsay reported no relevant financial disclosures.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
ASCO Updates Treatment Guidance for Newly Diagnosed, Advanced Ovarian Cancer
The American Society of Clinical Oncology (ASCO) has released updated guidelines for neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer, introducing changes in patient selection and treatment strategies. The changes reflect emerging evidence on racial disparities, treatment outcomes, and quality of life considerations.
The publication of the new guidance follows dramatic shifts in treatment patterns over the past decade.
“There had been a big shift in how we were treating patients in the United States,” explained Stephanie Gaillard, MD, PhD, one of the authors of the updated guidelines. “We saw a substantial drop in the number of patients undergoing primary cytoreductive surgery for ovarian cancer from about 70% of patients in 2010 to only about 37% in 2021.”
The new guidelines maintain the recommendation for platinum/taxane-based neoadjuvant chemotherapy but introduce modifications regarding timing and duration.
“It’s still a recommendation that gynecologic oncologists are involved in determining whether someone is eligible for primary cytoreductive surgery or should undergo neoadjuvant chemotherapy first,” Gaillard noted. “We emphasize that patients who are eligible for primary cytoreductive surgery should undergo surgery as opposed to receiving neoadjuvant chemotherapy.”
Alexander Melamed, MD, MPH, a gynecologic oncologist at Massachusetts General Hospital, Boston, who was not involved in authoring the updated guidelines, noted that additional evidence-based guidance is needed to individualize treatment plans. He pointed to four completed trials comparing neoadjuvant chemotherapy with cytoreductive surgery, noting: “When these trials have been pooled together in meta-analyses, there was a higher risk of mortality associated with primary cytoreductive surgery and a higher risk of severe complications.”
The updated guidelines take this higher risk for mortality with primary cytoreductive surgery into consideration, and patients who are not eligible for primary surgery would receive neoadjuvant chemotherapy, Gaillard noted.
Changes in Patient Selection
The 2025 guidelines describe a more nuanced approach for selecting patients for neoadjuvant chemotherapy vs primary cytoreductive surgery. While the 2016 ASCO guidelines primarily focused on disease burden and surgical resectability when selecting patients for neoadjuvant chemotherapy, the new recommendations incorporate additional factors.
The guidelines discuss recent findings showing that Black patients experience a 38% lower likelihood of undergoing cytoreductive surgery than non-Black patients. In addition, compared with non-Hispanic White women, Asian and Black women more frequently receive neoadjuvant chemotherapy with interval debulking surgery rather than primary cytoreductive surgery. According to the authors, these differences persist even after accounting for clinical factors, suggesting that structural barriers to healthcare access may play a role.
The guidelines discuss how affordability, availability, and accessibility mediate racial disparities in ovarian cancer care. According to the authors, structural inequities in healthcare access influence treatment quality for minority patients. Non-White patients face greater challenges in accessing gynecologic oncology consultations and standard-of-care combination therapy, leading to poorer survival outcomes, the guidelines say.
According to Melamed, the guidelines serve as an important tool for promoting healthcare equity. “Having recommendations and standards is incredibly important for achieving equity because once there is consensus on a best practice, it doesn’t matter if you’re rich, poor, or a patient of a particular racial or ethnic group — if you have the disease, you ought to have access to that standard,” he said.
The 2016 ASCO guidelines focused primarily on disease burden and surgical resectability, whereas the 2024 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for ovarian cancer focus more on oncologic outcomes and surgical considerations. Based on the NCCN guidelines, treatment selection for ovarian cancer is primarily determined by the histologic subtype, stage of disease, and whether the patient is a candidate for primary surgery. The 2025 ASCO guidelines, on the other hand, emphasize the importance of quality-of-life outcomes during treatment selection. The authors of the updated ASCO guidelines acknowledged that treatment decisions should consider both the duration and quality of life, particularly for elderly patients or those with multiple comorbidities.
Treatment Timing and Duration
The guidelines maintain the recommendations for platinum/taxane-based neoadjuvant chemotherapy described in the previous ASCO guidelines but introduce modifications regarding treatment timing and duration. The optimal window for interval cytoreductive surgery now falls after three to four chemotherapy cycles, allowing more individualized approaches based on patient response and tolerance.
In addition, postsurgical chemotherapy protocols have become more flexible. Rather than mandating a fixed number of cycles, the guidelines encourage tailoring treatment duration to individual patient factors including response assessment, performance status, and quality-of-life considerations.
The updated guidelines also emphasize the importance of genetic and molecular testing at diagnosis, which Melamed identifies as “absolutely central to treatment and deciding who receives maintenance therapy.” This is also recommended by the NCCN guidelines.
However, he highlighted the following practical challenge in molecular testing after neoadjuvant chemotherapy. “Probably 20% of patients have an exceptional response to neoadjuvant therapy, such that there is insufficient tissue at the time of their cytoreduction to do somatic testing,” he said.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
A notable difference between the 2016 and 2025 guidelines is the inclusion of HIPEC in the updated guidelines.
Commenting to this news organization, Gaillard explained the nuanced approach to HIPEC: “The committee discussed HIPEC extensively. We recognize that it may not be available at many centers and requires specially trained staff and dedicated resources. The reason for including HIPEC in the guidelines is to highlight that there have been studies that show a potential overall survival benefit.”
Melamed considers the recommendation of HIPEC to be one of the strongest aspects of the updated guidelines. “There have been two large trials and one smaller one that have shown that for patients treated with neoadjuvant chemotherapy, the addition of HIPEC appears to improve overall survival,” he explained.
Implementation Strategies
The authors acknowledged that barriers to healthcare delivery present significant challenges to the implementation of the guidelines. Limited access to gynecologic oncologists in rural areas, insurance coverage gaps, and varying surgical expertise across institutions complicate the delivery of optimal care. The guidelines also emphasize the need for solutions to ensure equitable access to recommended treatments.
Melamed noted that the decentralized structure of the healthcare system in the United States complicates the uniform adoption of guidelines, particularly in resource-limited settings, adding that “geographic region and local resources and expertise influence both access to treatment and outcomes.”
Although both the updated ASCO guidelines and NCCN guidelines emphasize the importance of evaluation by a gynecologic oncologist for determining the most appropriate treatment strategy, the scarcity of gynecologic oncologists is one of the most significant barriers to accessing optimal care, according to Gaillard. She proposes telemedicine consultations and enhanced communication between medical oncologists and gynecologic oncologists to ensure equitable access.
Gaillard also commented on the challenges in implementing a multidisciplinary treatment approach, the importance of which is emphasized in the updated guidelines.
“There can be a limited availability of the multidisciplinary team to be involved in this decision-making,” she said. “Ideally, patient assessment by a gynecologic oncologist would happen in person, but recognizing that availability is limited, it doesn’t necessarily have to. Sometimes, it can just be a conversation between a medical oncologist and a gynecologic oncologist detailing a treatment plan together.”
Looking Ahead
Gaillard noted that ovarian cancer is a very active field of research and that the guidelines may need to be updated again in the near future to incorporate novel treatment approaches.
“Newer and more effective targeted therapies based on tumor profiling are being developed,” she said. “These will hopefully move earlier in the treatment course for patients. Maybe we will not use chemotherapy in the future because we will have more directed and targeted therapies.”
She also emphasized the importance of early diagnosis in shaping future treatment guidelines for ovarian cancer.
“Neoadjuvant chemotherapy is predominantly used in situations where patients have very advanced disease and may not benefit from primary cytoreductive surgery,” she noted. “If we develop better diagnostic tools that will allow us to diagnose patients earlier, then we may not need to use neoadjuvant chemotherapy.”
All funding for the administration of the guideline development project was provided by ASCO. Gaillard reported receiving consulting or advisory fees from Verastem, Merck, AstraZeneca, and Compugen; research funding from AstraZeneca, Tesaro, Compugen, Genentech/Roche, Clovis Oncology, Tempest Therapeutics, Blueprint Pharmaceutic, Immunogen, Volastra Therapeutics, and Beigene; and patents, royalties, or other intellectual property from US Patent Nos 10,258,604 and 10,905,659, licensed by Duke University to Sermonix. Melamed reported receiving research funding from the National Cancer Institute and the National Institutes of Health.
A version of this article first appeared on Medscape.com.
The American Society of Clinical Oncology (ASCO) has released updated guidelines for neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer, introducing changes in patient selection and treatment strategies. The changes reflect emerging evidence on racial disparities, treatment outcomes, and quality of life considerations.
The publication of the new guidance follows dramatic shifts in treatment patterns over the past decade.
“There had been a big shift in how we were treating patients in the United States,” explained Stephanie Gaillard, MD, PhD, one of the authors of the updated guidelines. “We saw a substantial drop in the number of patients undergoing primary cytoreductive surgery for ovarian cancer from about 70% of patients in 2010 to only about 37% in 2021.”
The new guidelines maintain the recommendation for platinum/taxane-based neoadjuvant chemotherapy but introduce modifications regarding timing and duration.
“It’s still a recommendation that gynecologic oncologists are involved in determining whether someone is eligible for primary cytoreductive surgery or should undergo neoadjuvant chemotherapy first,” Gaillard noted. “We emphasize that patients who are eligible for primary cytoreductive surgery should undergo surgery as opposed to receiving neoadjuvant chemotherapy.”
Alexander Melamed, MD, MPH, a gynecologic oncologist at Massachusetts General Hospital, Boston, who was not involved in authoring the updated guidelines, noted that additional evidence-based guidance is needed to individualize treatment plans. He pointed to four completed trials comparing neoadjuvant chemotherapy with cytoreductive surgery, noting: “When these trials have been pooled together in meta-analyses, there was a higher risk of mortality associated with primary cytoreductive surgery and a higher risk of severe complications.”
The updated guidelines take this higher risk for mortality with primary cytoreductive surgery into consideration, and patients who are not eligible for primary surgery would receive neoadjuvant chemotherapy, Gaillard noted.
Changes in Patient Selection
The 2025 guidelines describe a more nuanced approach for selecting patients for neoadjuvant chemotherapy vs primary cytoreductive surgery. While the 2016 ASCO guidelines primarily focused on disease burden and surgical resectability when selecting patients for neoadjuvant chemotherapy, the new recommendations incorporate additional factors.
The guidelines discuss recent findings showing that Black patients experience a 38% lower likelihood of undergoing cytoreductive surgery than non-Black patients. In addition, compared with non-Hispanic White women, Asian and Black women more frequently receive neoadjuvant chemotherapy with interval debulking surgery rather than primary cytoreductive surgery. According to the authors, these differences persist even after accounting for clinical factors, suggesting that structural barriers to healthcare access may play a role.
The guidelines discuss how affordability, availability, and accessibility mediate racial disparities in ovarian cancer care. According to the authors, structural inequities in healthcare access influence treatment quality for minority patients. Non-White patients face greater challenges in accessing gynecologic oncology consultations and standard-of-care combination therapy, leading to poorer survival outcomes, the guidelines say.
According to Melamed, the guidelines serve as an important tool for promoting healthcare equity. “Having recommendations and standards is incredibly important for achieving equity because once there is consensus on a best practice, it doesn’t matter if you’re rich, poor, or a patient of a particular racial or ethnic group — if you have the disease, you ought to have access to that standard,” he said.
The 2016 ASCO guidelines focused primarily on disease burden and surgical resectability, whereas the 2024 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for ovarian cancer focus more on oncologic outcomes and surgical considerations. Based on the NCCN guidelines, treatment selection for ovarian cancer is primarily determined by the histologic subtype, stage of disease, and whether the patient is a candidate for primary surgery. The 2025 ASCO guidelines, on the other hand, emphasize the importance of quality-of-life outcomes during treatment selection. The authors of the updated ASCO guidelines acknowledged that treatment decisions should consider both the duration and quality of life, particularly for elderly patients or those with multiple comorbidities.
Treatment Timing and Duration
The guidelines maintain the recommendations for platinum/taxane-based neoadjuvant chemotherapy described in the previous ASCO guidelines but introduce modifications regarding treatment timing and duration. The optimal window for interval cytoreductive surgery now falls after three to four chemotherapy cycles, allowing more individualized approaches based on patient response and tolerance.
In addition, postsurgical chemotherapy protocols have become more flexible. Rather than mandating a fixed number of cycles, the guidelines encourage tailoring treatment duration to individual patient factors including response assessment, performance status, and quality-of-life considerations.
The updated guidelines also emphasize the importance of genetic and molecular testing at diagnosis, which Melamed identifies as “absolutely central to treatment and deciding who receives maintenance therapy.” This is also recommended by the NCCN guidelines.
However, he highlighted the following practical challenge in molecular testing after neoadjuvant chemotherapy. “Probably 20% of patients have an exceptional response to neoadjuvant therapy, such that there is insufficient tissue at the time of their cytoreduction to do somatic testing,” he said.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
A notable difference between the 2016 and 2025 guidelines is the inclusion of HIPEC in the updated guidelines.
Commenting to this news organization, Gaillard explained the nuanced approach to HIPEC: “The committee discussed HIPEC extensively. We recognize that it may not be available at many centers and requires specially trained staff and dedicated resources. The reason for including HIPEC in the guidelines is to highlight that there have been studies that show a potential overall survival benefit.”
Melamed considers the recommendation of HIPEC to be one of the strongest aspects of the updated guidelines. “There have been two large trials and one smaller one that have shown that for patients treated with neoadjuvant chemotherapy, the addition of HIPEC appears to improve overall survival,” he explained.
Implementation Strategies
The authors acknowledged that barriers to healthcare delivery present significant challenges to the implementation of the guidelines. Limited access to gynecologic oncologists in rural areas, insurance coverage gaps, and varying surgical expertise across institutions complicate the delivery of optimal care. The guidelines also emphasize the need for solutions to ensure equitable access to recommended treatments.
Melamed noted that the decentralized structure of the healthcare system in the United States complicates the uniform adoption of guidelines, particularly in resource-limited settings, adding that “geographic region and local resources and expertise influence both access to treatment and outcomes.”
Although both the updated ASCO guidelines and NCCN guidelines emphasize the importance of evaluation by a gynecologic oncologist for determining the most appropriate treatment strategy, the scarcity of gynecologic oncologists is one of the most significant barriers to accessing optimal care, according to Gaillard. She proposes telemedicine consultations and enhanced communication between medical oncologists and gynecologic oncologists to ensure equitable access.
Gaillard also commented on the challenges in implementing a multidisciplinary treatment approach, the importance of which is emphasized in the updated guidelines.
“There can be a limited availability of the multidisciplinary team to be involved in this decision-making,” she said. “Ideally, patient assessment by a gynecologic oncologist would happen in person, but recognizing that availability is limited, it doesn’t necessarily have to. Sometimes, it can just be a conversation between a medical oncologist and a gynecologic oncologist detailing a treatment plan together.”
Looking Ahead
Gaillard noted that ovarian cancer is a very active field of research and that the guidelines may need to be updated again in the near future to incorporate novel treatment approaches.
“Newer and more effective targeted therapies based on tumor profiling are being developed,” she said. “These will hopefully move earlier in the treatment course for patients. Maybe we will not use chemotherapy in the future because we will have more directed and targeted therapies.”
She also emphasized the importance of early diagnosis in shaping future treatment guidelines for ovarian cancer.
“Neoadjuvant chemotherapy is predominantly used in situations where patients have very advanced disease and may not benefit from primary cytoreductive surgery,” she noted. “If we develop better diagnostic tools that will allow us to diagnose patients earlier, then we may not need to use neoadjuvant chemotherapy.”
All funding for the administration of the guideline development project was provided by ASCO. Gaillard reported receiving consulting or advisory fees from Verastem, Merck, AstraZeneca, and Compugen; research funding from AstraZeneca, Tesaro, Compugen, Genentech/Roche, Clovis Oncology, Tempest Therapeutics, Blueprint Pharmaceutic, Immunogen, Volastra Therapeutics, and Beigene; and patents, royalties, or other intellectual property from US Patent Nos 10,258,604 and 10,905,659, licensed by Duke University to Sermonix. Melamed reported receiving research funding from the National Cancer Institute and the National Institutes of Health.
A version of this article first appeared on Medscape.com.
The American Society of Clinical Oncology (ASCO) has released updated guidelines for neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer, introducing changes in patient selection and treatment strategies. The changes reflect emerging evidence on racial disparities, treatment outcomes, and quality of life considerations.
The publication of the new guidance follows dramatic shifts in treatment patterns over the past decade.
“There had been a big shift in how we were treating patients in the United States,” explained Stephanie Gaillard, MD, PhD, one of the authors of the updated guidelines. “We saw a substantial drop in the number of patients undergoing primary cytoreductive surgery for ovarian cancer from about 70% of patients in 2010 to only about 37% in 2021.”
The new guidelines maintain the recommendation for platinum/taxane-based neoadjuvant chemotherapy but introduce modifications regarding timing and duration.
“It’s still a recommendation that gynecologic oncologists are involved in determining whether someone is eligible for primary cytoreductive surgery or should undergo neoadjuvant chemotherapy first,” Gaillard noted. “We emphasize that patients who are eligible for primary cytoreductive surgery should undergo surgery as opposed to receiving neoadjuvant chemotherapy.”
Alexander Melamed, MD, MPH, a gynecologic oncologist at Massachusetts General Hospital, Boston, who was not involved in authoring the updated guidelines, noted that additional evidence-based guidance is needed to individualize treatment plans. He pointed to four completed trials comparing neoadjuvant chemotherapy with cytoreductive surgery, noting: “When these trials have been pooled together in meta-analyses, there was a higher risk of mortality associated with primary cytoreductive surgery and a higher risk of severe complications.”
The updated guidelines take this higher risk for mortality with primary cytoreductive surgery into consideration, and patients who are not eligible for primary surgery would receive neoadjuvant chemotherapy, Gaillard noted.
Changes in Patient Selection
The 2025 guidelines describe a more nuanced approach for selecting patients for neoadjuvant chemotherapy vs primary cytoreductive surgery. While the 2016 ASCO guidelines primarily focused on disease burden and surgical resectability when selecting patients for neoadjuvant chemotherapy, the new recommendations incorporate additional factors.
The guidelines discuss recent findings showing that Black patients experience a 38% lower likelihood of undergoing cytoreductive surgery than non-Black patients. In addition, compared with non-Hispanic White women, Asian and Black women more frequently receive neoadjuvant chemotherapy with interval debulking surgery rather than primary cytoreductive surgery. According to the authors, these differences persist even after accounting for clinical factors, suggesting that structural barriers to healthcare access may play a role.
The guidelines discuss how affordability, availability, and accessibility mediate racial disparities in ovarian cancer care. According to the authors, structural inequities in healthcare access influence treatment quality for minority patients. Non-White patients face greater challenges in accessing gynecologic oncology consultations and standard-of-care combination therapy, leading to poorer survival outcomes, the guidelines say.
According to Melamed, the guidelines serve as an important tool for promoting healthcare equity. “Having recommendations and standards is incredibly important for achieving equity because once there is consensus on a best practice, it doesn’t matter if you’re rich, poor, or a patient of a particular racial or ethnic group — if you have the disease, you ought to have access to that standard,” he said.
The 2016 ASCO guidelines focused primarily on disease burden and surgical resectability, whereas the 2024 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for ovarian cancer focus more on oncologic outcomes and surgical considerations. Based on the NCCN guidelines, treatment selection for ovarian cancer is primarily determined by the histologic subtype, stage of disease, and whether the patient is a candidate for primary surgery. The 2025 ASCO guidelines, on the other hand, emphasize the importance of quality-of-life outcomes during treatment selection. The authors of the updated ASCO guidelines acknowledged that treatment decisions should consider both the duration and quality of life, particularly for elderly patients or those with multiple comorbidities.
Treatment Timing and Duration
The guidelines maintain the recommendations for platinum/taxane-based neoadjuvant chemotherapy described in the previous ASCO guidelines but introduce modifications regarding treatment timing and duration. The optimal window for interval cytoreductive surgery now falls after three to four chemotherapy cycles, allowing more individualized approaches based on patient response and tolerance.
In addition, postsurgical chemotherapy protocols have become more flexible. Rather than mandating a fixed number of cycles, the guidelines encourage tailoring treatment duration to individual patient factors including response assessment, performance status, and quality-of-life considerations.
The updated guidelines also emphasize the importance of genetic and molecular testing at diagnosis, which Melamed identifies as “absolutely central to treatment and deciding who receives maintenance therapy.” This is also recommended by the NCCN guidelines.
However, he highlighted the following practical challenge in molecular testing after neoadjuvant chemotherapy. “Probably 20% of patients have an exceptional response to neoadjuvant therapy, such that there is insufficient tissue at the time of their cytoreduction to do somatic testing,” he said.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
A notable difference between the 2016 and 2025 guidelines is the inclusion of HIPEC in the updated guidelines.
Commenting to this news organization, Gaillard explained the nuanced approach to HIPEC: “The committee discussed HIPEC extensively. We recognize that it may not be available at many centers and requires specially trained staff and dedicated resources. The reason for including HIPEC in the guidelines is to highlight that there have been studies that show a potential overall survival benefit.”
Melamed considers the recommendation of HIPEC to be one of the strongest aspects of the updated guidelines. “There have been two large trials and one smaller one that have shown that for patients treated with neoadjuvant chemotherapy, the addition of HIPEC appears to improve overall survival,” he explained.
Implementation Strategies
The authors acknowledged that barriers to healthcare delivery present significant challenges to the implementation of the guidelines. Limited access to gynecologic oncologists in rural areas, insurance coverage gaps, and varying surgical expertise across institutions complicate the delivery of optimal care. The guidelines also emphasize the need for solutions to ensure equitable access to recommended treatments.
Melamed noted that the decentralized structure of the healthcare system in the United States complicates the uniform adoption of guidelines, particularly in resource-limited settings, adding that “geographic region and local resources and expertise influence both access to treatment and outcomes.”
Although both the updated ASCO guidelines and NCCN guidelines emphasize the importance of evaluation by a gynecologic oncologist for determining the most appropriate treatment strategy, the scarcity of gynecologic oncologists is one of the most significant barriers to accessing optimal care, according to Gaillard. She proposes telemedicine consultations and enhanced communication between medical oncologists and gynecologic oncologists to ensure equitable access.
Gaillard also commented on the challenges in implementing a multidisciplinary treatment approach, the importance of which is emphasized in the updated guidelines.
“There can be a limited availability of the multidisciplinary team to be involved in this decision-making,” she said. “Ideally, patient assessment by a gynecologic oncologist would happen in person, but recognizing that availability is limited, it doesn’t necessarily have to. Sometimes, it can just be a conversation between a medical oncologist and a gynecologic oncologist detailing a treatment plan together.”
Looking Ahead
Gaillard noted that ovarian cancer is a very active field of research and that the guidelines may need to be updated again in the near future to incorporate novel treatment approaches.
“Newer and more effective targeted therapies based on tumor profiling are being developed,” she said. “These will hopefully move earlier in the treatment course for patients. Maybe we will not use chemotherapy in the future because we will have more directed and targeted therapies.”
She also emphasized the importance of early diagnosis in shaping future treatment guidelines for ovarian cancer.
“Neoadjuvant chemotherapy is predominantly used in situations where patients have very advanced disease and may not benefit from primary cytoreductive surgery,” she noted. “If we develop better diagnostic tools that will allow us to diagnose patients earlier, then we may not need to use neoadjuvant chemotherapy.”
All funding for the administration of the guideline development project was provided by ASCO. Gaillard reported receiving consulting or advisory fees from Verastem, Merck, AstraZeneca, and Compugen; research funding from AstraZeneca, Tesaro, Compugen, Genentech/Roche, Clovis Oncology, Tempest Therapeutics, Blueprint Pharmaceutic, Immunogen, Volastra Therapeutics, and Beigene; and patents, royalties, or other intellectual property from US Patent Nos 10,258,604 and 10,905,659, licensed by Duke University to Sermonix. Melamed reported receiving research funding from the National Cancer Institute and the National Institutes of Health.
A version of this article first appeared on Medscape.com.
