Key clinical point: Radiation therapy (RT) as a bridging or salvage approach leads to favorable in‐field control and minimal toxicity in patients with relapsed or refractory mantle cell lymphoma (MCL) undergoing CD19‐targeted chimeric antigen receptor (CAR) T‐cell therapy.

Major finding: At a median RT dose of 15 Gy, the in-field complete response and partial response rates were 86% and 14%, respectively, with a 100% local control rate. Low-dose RT (3.6-6 Gy) achieved similar rates of in-field complete response (70%) and partial response (30%), with the local control rate remaining unchanged. Only one patient experienced grade 3 RT dermatitis after undergoing 40 Gy RT in 16 fractions.

Study details: This retrospective study included 21 patients with relapsed or refractory MCL who were treated with CD19‐targeted CAR T‐cell therapy, of whom 7 patients received prior bridging RT, post‐CAR T salvage RT, or both at 23 sites.

Disclosures: This study did not report any funding source. MJ Frigault declared serving as a consultant for and receiving research funding from various organizations.

Source: Ababneh HS et al. Radiation therapy for patients with relapsed or refractory mantle cell lymphoma undergoing CD19-targeted chimeric antigen receptor T-cell therapy. Hematol Oncol. 2023 (Sep 7). doi: 10.1002/hon.3221

Key clinical point: Radiation therapy (RT) as a bridging or salvage approach leads to favorable in‐field control and minimal toxicity in patients with relapsed or refractory mantle cell lymphoma (MCL) undergoing CD19‐targeted chimeric antigen receptor (CAR) T‐cell therapy.

Major finding: At a median RT dose of 15 Gy, the in-field complete response and partial response rates were 86% and 14%, respectively, with a 100% local control rate. Low-dose RT (3.6-6 Gy) achieved similar rates of in-field complete response (70%) and partial response (30%), with the local control rate remaining unchanged. Only one patient experienced grade 3 RT dermatitis after undergoing 40 Gy RT in 16 fractions.

Study details: This retrospective study included 21 patients with relapsed or refractory MCL who were treated with CD19‐targeted CAR T‐cell therapy, of whom 7 patients received prior bridging RT, post‐CAR T salvage RT, or both at 23 sites.

Disclosures: This study did not report any funding source. MJ Frigault declared serving as a consultant for and receiving research funding from various organizations.

Source: Ababneh HS et al. Radiation therapy for patients with relapsed or refractory mantle cell lymphoma undergoing CD19-targeted chimeric antigen receptor T-cell therapy. Hematol Oncol. 2023 (Sep 7). doi: 10.1002/hon.3221

Key clinical point: Radiation therapy (RT) as a bridging or salvage approach leads to favorable in‐field control and minimal toxicity in patients with relapsed or refractory mantle cell lymphoma (MCL) undergoing CD19‐targeted chimeric antigen receptor (CAR) T‐cell therapy.

Major finding: At a median RT dose of 15 Gy, the in-field complete response and partial response rates were 86% and 14%, respectively, with a 100% local control rate. Low-dose RT (3.6-6 Gy) achieved similar rates of in-field complete response (70%) and partial response (30%), with the local control rate remaining unchanged. Only one patient experienced grade 3 RT dermatitis after undergoing 40 Gy RT in 16 fractions.

Study details: This retrospective study included 21 patients with relapsed or refractory MCL who were treated with CD19‐targeted CAR T‐cell therapy, of whom 7 patients received prior bridging RT, post‐CAR T salvage RT, or both at 23 sites.

Disclosures: This study did not report any funding source. MJ Frigault declared serving as a consultant for and receiving research funding from various organizations.

Source: Ababneh HS et al. Radiation therapy for patients with relapsed or refractory mantle cell lymphoma undergoing CD19-targeted chimeric antigen receptor T-cell therapy. Hematol Oncol. 2023 (Sep 7). doi: 10.1002/hon.3221

Key clinical point: In low endemic areas for hepatitis B surface antigen, patients with past or active hepatitis B virus (HBV) infections have an increased risk for diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients with DLBCL, but not with various types of indolent B-cell non-Hodgkin lymphomas (NHL), had a significantly higher prevalence of chronic (P = .008) and past (P = 0.002) HBV infections vs HBV-negative serology. The DLBCL vs pooled indolent B-cell NHL group had a significantly higher prevalence of chronic (adjusted odds ratio [aOR] 2.8; P = .014) and past (aOR 2.4; P = .0006) HBV infections.

Study details: This retrospective single-center study included patients with DLBCL (n = 253) or different types of indolent B-cell NHL (n = 694) who had either chronic or past HBV infections or no serological evidence for either.

Disclosures: This study was supported by grants from the Intramural Research Program of Sapienza University of Rome. The authors declared no conflicts of interest.

Source: Visentini M et al. High prevalence of past hepatitis B virus infection in diffuse large B cell lymphoma: A retrospective study from Italy. Ann Hematol. 2023 (Aug 31). doi: 10.1007/s00277-023-05412-1

Key clinical point: In low endemic areas for hepatitis B surface antigen, patients with past or active hepatitis B virus (HBV) infections have an increased risk for diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients with DLBCL, but not with various types of indolent B-cell non-Hodgkin lymphomas (NHL), had a significantly higher prevalence of chronic (P = .008) and past (P = 0.002) HBV infections vs HBV-negative serology. The DLBCL vs pooled indolent B-cell NHL group had a significantly higher prevalence of chronic (adjusted odds ratio [aOR] 2.8; P = .014) and past (aOR 2.4; P = .0006) HBV infections.

Study details: This retrospective single-center study included patients with DLBCL (n = 253) or different types of indolent B-cell NHL (n = 694) who had either chronic or past HBV infections or no serological evidence for either.

Disclosures: This study was supported by grants from the Intramural Research Program of Sapienza University of Rome. The authors declared no conflicts of interest.

Source: Visentini M et al. High prevalence of past hepatitis B virus infection in diffuse large B cell lymphoma: A retrospective study from Italy. Ann Hematol. 2023 (Aug 31). doi: 10.1007/s00277-023-05412-1

Key clinical point: In low endemic areas for hepatitis B surface antigen, patients with past or active hepatitis B virus (HBV) infections have an increased risk for diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients with DLBCL, but not with various types of indolent B-cell non-Hodgkin lymphomas (NHL), had a significantly higher prevalence of chronic (P = .008) and past (P = 0.002) HBV infections vs HBV-negative serology. The DLBCL vs pooled indolent B-cell NHL group had a significantly higher prevalence of chronic (adjusted odds ratio [aOR] 2.8; P = .014) and past (aOR 2.4; P = .0006) HBV infections.

Study details: This retrospective single-center study included patients with DLBCL (n = 253) or different types of indolent B-cell NHL (n = 694) who had either chronic or past HBV infections or no serological evidence for either.

Disclosures: This study was supported by grants from the Intramural Research Program of Sapienza University of Rome. The authors declared no conflicts of interest.

Source: Visentini M et al. High prevalence of past hepatitis B virus infection in diffuse large B cell lymphoma: A retrospective study from Italy. Ann Hematol. 2023 (Aug 31). doi: 10.1007/s00277-023-05412-1

Key clinical point: Bendamustine lymphodepletion (LD) relative to fludarabine/cyclophosphamide (Flu/Cy) LD prior to axicabtagene ciloleucel (axi-cel) therapy leads to comparable efficacy and lower rates of any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with relapsed or refractory aggressive B-cell lymphoma (aBCL).

Major finding: The bendamustine and Flu/Cy cohorts had similar rates of best overall response (77.8%, 95% CI 57.7%-91.4%; and 81.0%, 95% CI 65.9%-91.4%, respectively) and complete response (48.1%, 95% CI 28.7%-68.1%; and 50.0%, 95% CI 34.2%-65.8%, respectively), 6-month progression-free survival (43.8%, 95% CI 24.7%-61.3%; and 55.6%, 95% CI 39.0%-69.3%, respectively), and 6-month overall survival (81.5%, 95% CI 61.1%-91.8%; and 90.4%, 95% CI 76.4%-96.3%, respectively). Bendamustine vs Flu/Cy was associated with decreased odds of any-grade ICANS (odds ratio 0.35; 95% CI 0.12-0.97).

Study details: This retrospective study included patients with relapsed or refractory aBCL who received bendamustine (n = 27) or Flu/Cy (n = 42) LD before axi-cel therapy.

Disclosures: This study did not receive any funding. Some authors declared serving as speaker's bureau members or consultants for or receiving research funding or honoraria from various organizations.

Source: Ong SY et al. Bendamustine lymphodepletion is a well-tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B-cell lymphoma. Am J Hematol. 2023 (Sep 5). doi: 10.1002/ajh.27069

Key clinical point: Bendamustine lymphodepletion (LD) relative to fludarabine/cyclophosphamide (Flu/Cy) LD prior to axicabtagene ciloleucel (axi-cel) therapy leads to comparable efficacy and lower rates of any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with relapsed or refractory aggressive B-cell lymphoma (aBCL).

Major finding: The bendamustine and Flu/Cy cohorts had similar rates of best overall response (77.8%, 95% CI 57.7%-91.4%; and 81.0%, 95% CI 65.9%-91.4%, respectively) and complete response (48.1%, 95% CI 28.7%-68.1%; and 50.0%, 95% CI 34.2%-65.8%, respectively), 6-month progression-free survival (43.8%, 95% CI 24.7%-61.3%; and 55.6%, 95% CI 39.0%-69.3%, respectively), and 6-month overall survival (81.5%, 95% CI 61.1%-91.8%; and 90.4%, 95% CI 76.4%-96.3%, respectively). Bendamustine vs Flu/Cy was associated with decreased odds of any-grade ICANS (odds ratio 0.35; 95% CI 0.12-0.97).

Study details: This retrospective study included patients with relapsed or refractory aBCL who received bendamustine (n = 27) or Flu/Cy (n = 42) LD before axi-cel therapy.

Disclosures: This study did not receive any funding. Some authors declared serving as speaker's bureau members or consultants for or receiving research funding or honoraria from various organizations.

Source: Ong SY et al. Bendamustine lymphodepletion is a well-tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B-cell lymphoma. Am J Hematol. 2023 (Sep 5). doi: 10.1002/ajh.27069

Key clinical point: Bendamustine lymphodepletion (LD) relative to fludarabine/cyclophosphamide (Flu/Cy) LD prior to axicabtagene ciloleucel (axi-cel) therapy leads to comparable efficacy and lower rates of any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with relapsed or refractory aggressive B-cell lymphoma (aBCL).

Major finding: The bendamustine and Flu/Cy cohorts had similar rates of best overall response (77.8%, 95% CI 57.7%-91.4%; and 81.0%, 95% CI 65.9%-91.4%, respectively) and complete response (48.1%, 95% CI 28.7%-68.1%; and 50.0%, 95% CI 34.2%-65.8%, respectively), 6-month progression-free survival (43.8%, 95% CI 24.7%-61.3%; and 55.6%, 95% CI 39.0%-69.3%, respectively), and 6-month overall survival (81.5%, 95% CI 61.1%-91.8%; and 90.4%, 95% CI 76.4%-96.3%, respectively). Bendamustine vs Flu/Cy was associated with decreased odds of any-grade ICANS (odds ratio 0.35; 95% CI 0.12-0.97).

Study details: This retrospective study included patients with relapsed or refractory aBCL who received bendamustine (n = 27) or Flu/Cy (n = 42) LD before axi-cel therapy.

Disclosures: This study did not receive any funding. Some authors declared serving as speaker's bureau members or consultants for or receiving research funding or honoraria from various organizations.

Source: Ong SY et al. Bendamustine lymphodepletion is a well-tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B-cell lymphoma. Am J Hematol. 2023 (Sep 5). doi: 10.1002/ajh.27069

Key clinical point: Concurrent MYC overexpression and TP53/p53 alterations in tumors identifies a subset of patients with mantle cell lymphoma (MCL) having a poor prognosis with a median overall survival < 3 years.

Major finding: Patients with tumors comprising > 20% cells with MYC overexpression (MYC^high tumors) vs MYC^low tumors had significantly higher risks for death (adjusted hazard ratio [aHR] 2.03; P = .007) and disease progression (aHR 2.20; P = .04). Patients with tumors with concomitant MYC^high expression and TP53/p53 alterations vs MYC^low tumors had significantly increased risks for progression (HR 16.90) and death (HR 7.83) with a median overall survival of 0.9 years only (both P < .001).

Study details: The data come from a study including 252 patients with MCL, 14% of whom had MYC^high tumors, including 13 patients with concomitant MYC^high expression and TP53/p53 alterations.

Disclosures: This study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. Some authors declared receiving research support or honoraria from or participating in educational sessions or advisory boards of various organizations.

Source: Rodrigues JM et al. MYC protein is a high-risk factor in mantle cell lymphoma and identifies cases beyond morphology, proliferation and TP53/p53 - A Nordic Lymphoma Group study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283352

Key clinical point: Concurrent MYC overexpression and TP53/p53 alterations in tumors identifies a subset of patients with mantle cell lymphoma (MCL) having a poor prognosis with a median overall survival < 3 years.

Major finding: Patients with tumors comprising > 20% cells with MYC overexpression (MYC^high tumors) vs MYC^low tumors had significantly higher risks for death (adjusted hazard ratio [aHR] 2.03; P = .007) and disease progression (aHR 2.20; P = .04). Patients with tumors with concomitant MYC^high expression and TP53/p53 alterations vs MYC^low tumors had significantly increased risks for progression (HR 16.90) and death (HR 7.83) with a median overall survival of 0.9 years only (both P < .001).

Study details: The data come from a study including 252 patients with MCL, 14% of whom had MYC^high tumors, including 13 patients with concomitant MYC^high expression and TP53/p53 alterations.

Disclosures: This study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. Some authors declared receiving research support or honoraria from or participating in educational sessions or advisory boards of various organizations.

Source: Rodrigues JM et al. MYC protein is a high-risk factor in mantle cell lymphoma and identifies cases beyond morphology, proliferation and TP53/p53 - A Nordic Lymphoma Group study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283352

Key clinical point: Concurrent MYC overexpression and TP53/p53 alterations in tumors identifies a subset of patients with mantle cell lymphoma (MCL) having a poor prognosis with a median overall survival < 3 years.

Major finding: Patients with tumors comprising > 20% cells with MYC overexpression (MYC^high tumors) vs MYC^low tumors had significantly higher risks for death (adjusted hazard ratio [aHR] 2.03; P = .007) and disease progression (aHR 2.20; P = .04). Patients with tumors with concomitant MYC^high expression and TP53/p53 alterations vs MYC^low tumors had significantly increased risks for progression (HR 16.90) and death (HR 7.83) with a median overall survival of 0.9 years only (both P < .001).

Study details: The data come from a study including 252 patients with MCL, 14% of whom had MYC^high tumors, including 13 patients with concomitant MYC^high expression and TP53/p53 alterations.

Disclosures: This study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. Some authors declared receiving research support or honoraria from or participating in educational sessions or advisory boards of various organizations.

Source: Rodrigues JM et al. MYC protein is a high-risk factor in mantle cell lymphoma and identifies cases beyond morphology, proliferation and TP53/p53 - A Nordic Lymphoma Group study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283352

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Poor adherence to medication is a real challenge in health care. Despite evidence indicating therapeutic benefit from adhering to a prescribed regimen, it is estimated that around 50% of patients around the world don’t take their medication as it is prescribed – and some simply don’t take them at all.

Nonadherence to medication can be primary or secondary. Primary medication nonadherence occurs when a new medication is prescribed for a patient, but the patient does not obtain the medication or an appropriate alternative within an acceptable period after it was prescribed. Secondary nonadherence measures prescription refills among patients who previously filled their first prescriptions. With most medication adherence research to date focused on secondary nonadherence, PMN has been identified as a major research gap.

Growth in electronic prescribing has partially resolved this issue, and new measures have emerged linking electronic prescribing databases with pharmacy dispensing databases. A study conducted in a network of primary care services in Canada has sought to identify the predictive factors of primary nonadherence and which drugs could be at greatest risk of primary nonadherence when prescribed by a primary care physician
 

Adherence measures

Measuring medication adherence is challenging but can be done using various approaches. It comprises the following approaches:

• Subjective measurements obtained by asking patients, family members, caregivers, and physicians about the patient’s medication use
• Objective measurements obtained by counting pills, examining pharmacy refill records, or using electronic medication event monitoring systems
• Biochemical measurements obtained by adding a nontoxic marker to the medication and detecting its presence in blood or urine or measurement of serum drug levels.

Determining factors

A myriad of factors contributes to poor medication adherence. Some are related to patients (e.g., suboptimal health literacy and lack of involvement in the treatment decision-making process), others are related to physicians (e.g., prescription of complex drug regimens, communication barriers, ineffective communication of information about adverse effects, and provision of care by multiple physicians), and still others are related to health care systems (e.g., office visit time limitations, limited access to care, and lack of health information technology).

Primary nonadherence

The literature has reported substantial variation in primary nonadherence, with estimates ranging from as little as 1.9% of incident prescriptions never filled to as much as 75%.

Investigators for the Canadian study estimated the rate of primary nonadherence, defined as failure to dispense a new medication or its equivalent within 6 months of the prescription date, using data from 150,565 new prescriptions issued to 34,243 patients.
 

Rate of nonadherence

The following patterns of primary nonadherence were observed:

• Primary nonadherence was lowest for prescriptions issued by prescribers aged 35 years or younger (17.1%) and male prescribers (15.1%).
• It was similar among patients of both sexes.
• It was lowest in the oldest subjects, decreasing with age (odds ratio, 0.91 for each additional 10 years).
• It was highest for drugs prescribed mostly on an as-needed basis, including topical corticosteroids (35.1%) and antihistamines (23.4%).

Predictors of nonadherence

The odds of primary nonadherence exhibited the following patterns:

• Lower for prescriptions issued by male clinicians (OR, 0.66)
• Significantly greater, compared with anti-infectives, for dermatological agents (OR, 1.36) and lowest for cardiovascular agents (OR, 0.46).
• Lower across therapeutic drug categories (except for respiratory agents) for those aged 65 years and older than for those younger than age 65.

In conclusion, in a general medicine setting, the odds of primary nonadherence were higher for younger patients, those who received primary care services from female prescribers, and older patients who were prescribed more medications. Across therapeutic categories, the odds of primary nonadherence were lowest for cardiovascular system agents and highest for dermatological agents.

To date, the lack of a standardized terminology, operational definition, and measurement methods of primary nonadherence has limited our understanding of the extent to which patients do not avail themselves of prescriber-ordered pharmaceutical treatment. These results reaffirm the need to compare the prevalence of such nonadherence in different health care settings.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Poor adherence to medication is a real challenge in health care. Despite evidence indicating therapeutic benefit from adhering to a prescribed regimen, it is estimated that around 50% of patients around the world don’t take their medication as it is prescribed – and some simply don’t take them at all.

Nonadherence to medication can be primary or secondary. Primary medication nonadherence occurs when a new medication is prescribed for a patient, but the patient does not obtain the medication or an appropriate alternative within an acceptable period after it was prescribed. Secondary nonadherence measures prescription refills among patients who previously filled their first prescriptions. With most medication adherence research to date focused on secondary nonadherence, PMN has been identified as a major research gap.

Growth in electronic prescribing has partially resolved this issue, and new measures have emerged linking electronic prescribing databases with pharmacy dispensing databases. A study conducted in a network of primary care services in Canada has sought to identify the predictive factors of primary nonadherence and which drugs could be at greatest risk of primary nonadherence when prescribed by a primary care physician
 

Adherence measures

Measuring medication adherence is challenging but can be done using various approaches. It comprises the following approaches:

• Subjective measurements obtained by asking patients, family members, caregivers, and physicians about the patient’s medication use
• Objective measurements obtained by counting pills, examining pharmacy refill records, or using electronic medication event monitoring systems
• Biochemical measurements obtained by adding a nontoxic marker to the medication and detecting its presence in blood or urine or measurement of serum drug levels.

Determining factors

A myriad of factors contributes to poor medication adherence. Some are related to patients (e.g., suboptimal health literacy and lack of involvement in the treatment decision-making process), others are related to physicians (e.g., prescription of complex drug regimens, communication barriers, ineffective communication of information about adverse effects, and provision of care by multiple physicians), and still others are related to health care systems (e.g., office visit time limitations, limited access to care, and lack of health information technology).

Primary nonadherence

The literature has reported substantial variation in primary nonadherence, with estimates ranging from as little as 1.9% of incident prescriptions never filled to as much as 75%.

Investigators for the Canadian study estimated the rate of primary nonadherence, defined as failure to dispense a new medication or its equivalent within 6 months of the prescription date, using data from 150,565 new prescriptions issued to 34,243 patients.
 

Rate of nonadherence

The following patterns of primary nonadherence were observed:

• Primary nonadherence was lowest for prescriptions issued by prescribers aged 35 years or younger (17.1%) and male prescribers (15.1%).
• It was similar among patients of both sexes.
• It was lowest in the oldest subjects, decreasing with age (odds ratio, 0.91 for each additional 10 years).
• It was highest for drugs prescribed mostly on an as-needed basis, including topical corticosteroids (35.1%) and antihistamines (23.4%).

Predictors of nonadherence

The odds of primary nonadherence exhibited the following patterns:

• Lower for prescriptions issued by male clinicians (OR, 0.66)
• Significantly greater, compared with anti-infectives, for dermatological agents (OR, 1.36) and lowest for cardiovascular agents (OR, 0.46).
• Lower across therapeutic drug categories (except for respiratory agents) for those aged 65 years and older than for those younger than age 65.

In conclusion, in a general medicine setting, the odds of primary nonadherence were higher for younger patients, those who received primary care services from female prescribers, and older patients who were prescribed more medications. Across therapeutic categories, the odds of primary nonadherence were lowest for cardiovascular system agents and highest for dermatological agents.

To date, the lack of a standardized terminology, operational definition, and measurement methods of primary nonadherence has limited our understanding of the extent to which patients do not avail themselves of prescriber-ordered pharmaceutical treatment. These results reaffirm the need to compare the prevalence of such nonadherence in different health care settings.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Poor adherence to medication is a real challenge in health care. Despite evidence indicating therapeutic benefit from adhering to a prescribed regimen, it is estimated that around 50% of patients around the world don’t take their medication as it is prescribed – and some simply don’t take them at all.

Nonadherence to medication can be primary or secondary. Primary medication nonadherence occurs when a new medication is prescribed for a patient, but the patient does not obtain the medication or an appropriate alternative within an acceptable period after it was prescribed. Secondary nonadherence measures prescription refills among patients who previously filled their first prescriptions. With most medication adherence research to date focused on secondary nonadherence, PMN has been identified as a major research gap.

Growth in electronic prescribing has partially resolved this issue, and new measures have emerged linking electronic prescribing databases with pharmacy dispensing databases. A study conducted in a network of primary care services in Canada has sought to identify the predictive factors of primary nonadherence and which drugs could be at greatest risk of primary nonadherence when prescribed by a primary care physician
 

Adherence measures

Measuring medication adherence is challenging but can be done using various approaches. It comprises the following approaches:

• Subjective measurements obtained by asking patients, family members, caregivers, and physicians about the patient’s medication use
• Objective measurements obtained by counting pills, examining pharmacy refill records, or using electronic medication event monitoring systems
• Biochemical measurements obtained by adding a nontoxic marker to the medication and detecting its presence in blood or urine or measurement of serum drug levels.

Determining factors

A myriad of factors contributes to poor medication adherence. Some are related to patients (e.g., suboptimal health literacy and lack of involvement in the treatment decision-making process), others are related to physicians (e.g., prescription of complex drug regimens, communication barriers, ineffective communication of information about adverse effects, and provision of care by multiple physicians), and still others are related to health care systems (e.g., office visit time limitations, limited access to care, and lack of health information technology).

Primary nonadherence

The literature has reported substantial variation in primary nonadherence, with estimates ranging from as little as 1.9% of incident prescriptions never filled to as much as 75%.

Investigators for the Canadian study estimated the rate of primary nonadherence, defined as failure to dispense a new medication or its equivalent within 6 months of the prescription date, using data from 150,565 new prescriptions issued to 34,243 patients.
 

Rate of nonadherence

The following patterns of primary nonadherence were observed:

• Primary nonadherence was lowest for prescriptions issued by prescribers aged 35 years or younger (17.1%) and male prescribers (15.1%).
• It was similar among patients of both sexes.
• It was lowest in the oldest subjects, decreasing with age (odds ratio, 0.91 for each additional 10 years).
• It was highest for drugs prescribed mostly on an as-needed basis, including topical corticosteroids (35.1%) and antihistamines (23.4%).

Predictors of nonadherence

The odds of primary nonadherence exhibited the following patterns:

• Lower for prescriptions issued by male clinicians (OR, 0.66)
• Significantly greater, compared with anti-infectives, for dermatological agents (OR, 1.36) and lowest for cardiovascular agents (OR, 0.46).
• Lower across therapeutic drug categories (except for respiratory agents) for those aged 65 years and older than for those younger than age 65.

In conclusion, in a general medicine setting, the odds of primary nonadherence were higher for younger patients, those who received primary care services from female prescribers, and older patients who were prescribed more medications. Across therapeutic categories, the odds of primary nonadherence were lowest for cardiovascular system agents and highest for dermatological agents.

To date, the lack of a standardized terminology, operational definition, and measurement methods of primary nonadherence has limited our understanding of the extent to which patients do not avail themselves of prescriber-ordered pharmaceutical treatment. These results reaffirm the need to compare the prevalence of such nonadherence in different health care settings.

This article was translated from Univadis Italy. A version appeared on Medscape.com.