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BARCELONA—Results from 2 studies suggest an immunogene therapy can provide a clinical benefit in adults with high-risk hematologic malignancies undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT).
When compared to historical controls, patients who received the immunogene therapy, Zalmoxis, had lower rates of non-relapse mortality (NRM) and chronic graft-vs-host disease (GVHD), as well as improved overall survival (OS).
The only adverse event related to Zalmoxis was GVHD, which was resolved.
These data were presented at the EBMT International Transplant Course. The studies were funded by MolMed S.p.A., the company developing Zalmoxis.
About the therapy
Zalmoxis is a treatment consisting of allogeneic, genetically modified T cells. The cells are intended to be given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.
Because the genetically modified T cells can also cause GVHD, they are equipped with a suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of GVHD.
Trial data
The data presented at the EBMT International Transplant Course were from the phase 1/2 TK007 trial and the ongoing phase 3 TK008 trial.
The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, while the TK008 trial is enrolling patients with high-risk acute leukemia who are undergoing haplo-HSCT.
Researchers have compared 37 Zalmoxis-treated patients from these trials to 140 contemporaneous control patients from the database of the EBMT registry.
Results of this pair-matched analysis showed an OS improvement in Zalmoxis-treated patients, which was driven by a reduction in NRM. The OS was 49% in the Zalmoxis group and 37% in controls (P=0.01), and the NRM was 22% and 43%, respectively (P=0.014).
Among controls dying from non-relapse causes, the majority (78%) died from either infection (56%) or GVHD (22%), while the only adverse event related to Zalmoxis treatment was GVHD. And this GVHD was fully resolved by activating the suicide-gene system with ganciclovir treatment, without any GVHD-related death.
Furthermore, the incidence of chronic GVHD was lower in Zalmoxis-treated patients than in controls—6% and 25%, respectively (P=0.04).
Therefore, the researchers concluded that the protective effects of Zalmoxis in controlling infection and GVHD mainly drove the decreased NRM in the Zalmoxis group.
These data supported the European Commission’s recent decision to grant conditional marketing authorization for Zalmoxis. 
Photo by Chad McNeeley
BARCELONA—Results from 2 studies suggest an immunogene therapy can provide a clinical benefit in adults with high-risk hematologic malignancies undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT).
When compared to historical controls, patients who received the immunogene therapy, Zalmoxis, had lower rates of non-relapse mortality (NRM) and chronic graft-vs-host disease (GVHD), as well as improved overall survival (OS).
The only adverse event related to Zalmoxis was GVHD, which was resolved.
These data were presented at the EBMT International Transplant Course. The studies were funded by MolMed S.p.A., the company developing Zalmoxis.
About the therapy
Zalmoxis is a treatment consisting of allogeneic, genetically modified T cells. The cells are intended to be given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.
Because the genetically modified T cells can also cause GVHD, they are equipped with a suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of GVHD.
Trial data
The data presented at the EBMT International Transplant Course were from the phase 1/2 TK007 trial and the ongoing phase 3 TK008 trial.
The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, while the TK008 trial is enrolling patients with high-risk acute leukemia who are undergoing haplo-HSCT.
Researchers have compared 37 Zalmoxis-treated patients from these trials to 140 contemporaneous control patients from the database of the EBMT registry.
Results of this pair-matched analysis showed an OS improvement in Zalmoxis-treated patients, which was driven by a reduction in NRM. The OS was 49% in the Zalmoxis group and 37% in controls (P=0.01), and the NRM was 22% and 43%, respectively (P=0.014).
Among controls dying from non-relapse causes, the majority (78%) died from either infection (56%) or GVHD (22%), while the only adverse event related to Zalmoxis treatment was GVHD. And this GVHD was fully resolved by activating the suicide-gene system with ganciclovir treatment, without any GVHD-related death.
Furthermore, the incidence of chronic GVHD was lower in Zalmoxis-treated patients than in controls—6% and 25%, respectively (P=0.04).
Therefore, the researchers concluded that the protective effects of Zalmoxis in controlling infection and GVHD mainly drove the decreased NRM in the Zalmoxis group.
These data supported the European Commission’s recent decision to grant conditional marketing authorization for Zalmoxis.
Photo by Chad McNeeley
BARCELONA—Results from 2 studies suggest an immunogene therapy can provide a clinical benefit in adults with high-risk hematologic malignancies undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT).
When compared to historical controls, patients who received the immunogene therapy, Zalmoxis, had lower rates of non-relapse mortality (NRM) and chronic graft-vs-host disease (GVHD), as well as improved overall survival (OS).
The only adverse event related to Zalmoxis was GVHD, which was resolved.
These data were presented at the EBMT International Transplant Course. The studies were funded by MolMed S.p.A., the company developing Zalmoxis.
About the therapy
Zalmoxis is a treatment consisting of allogeneic, genetically modified T cells. The cells are intended to be given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.
Because the genetically modified T cells can also cause GVHD, they are equipped with a suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of GVHD.
Trial data
The data presented at the EBMT International Transplant Course were from the phase 1/2 TK007 trial and the ongoing phase 3 TK008 trial.
The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, while the TK008 trial is enrolling patients with high-risk acute leukemia who are undergoing haplo-HSCT.
Researchers have compared 37 Zalmoxis-treated patients from these trials to 140 contemporaneous control patients from the database of the EBMT registry.
Results of this pair-matched analysis showed an OS improvement in Zalmoxis-treated patients, which was driven by a reduction in NRM. The OS was 49% in the Zalmoxis group and 37% in controls (P=0.01), and the NRM was 22% and 43%, respectively (P=0.014).
Among controls dying from non-relapse causes, the majority (78%) died from either infection (56%) or GVHD (22%), while the only adverse event related to Zalmoxis treatment was GVHD. And this GVHD was fully resolved by activating the suicide-gene system with ganciclovir treatment, without any GVHD-related death.
Furthermore, the incidence of chronic GVHD was lower in Zalmoxis-treated patients than in controls—6% and 25%, respectively (P=0.04).
Therefore, the researchers concluded that the protective effects of Zalmoxis in controlling infection and GVHD mainly drove the decreased NRM in the Zalmoxis group.
These data supported the European Commission’s recent decision to grant conditional marketing authorization for Zalmoxis.