Second-line CAR-T fails to extend EFS in aggressive B-cell non-Hodgkin lymphoma
Click Here to Manage Email Alerts
A randomized phase 3 trial that evaluated tisagenlecleucel as second-line treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma failed to meet its primary endpoint of improved EFS, according to the agent’s manufacturer.
The multicenter BELINDA trial included patients who had primary refractory disease or whose disease relapsed within 12 months of first-line treatment.
Researchers randomly assigned patients to tisagenlecleucel (Kymriah, Novartis) — an autologous, gene-edited, CD19-directed chimeric antigen receptor T-cell therapy — or standard of care. The standard regimen consisted of salvage chemotherapy, and patients who responded subsequently received high-dose chemotherapy and autologous hematopoietic stem cell transplant.
EFS assessed by blinded independent review committee served as the primary endpoint. Secondary endpoints included EFS by local investigator assessment, OS, overall response rate, duration of response, time to response and safety.
Patients assigned standard of care could cross over to tisagenlecleucel upon progression as determined by a blinded independent review.
Results showed no EFS benefit with tisagenlecleucel.
“We were hopeful the BELINDA study would show that Kymriah could improve outcomes and the overall treatment experience for these patients in need,” Michael R. Bishop, MD, director of the hematopoietic stem cell transplantation program at University of Chicago Medicine and BELINDA trial steering committee chair, said in a Novartis-issued press release. “The study investigators will work together with Novartis in the coming weeks and months to understand the factors that contributed to this outcome.”
Researchers observed no new safety signals.
Tisagenlecleucel is approved in the United States for children and young adults with relapsed or refractory acute lymphoblastic leukemia and adults with relapsed or refractory diffuse large B-cell lymphoma. Both FDA-approved indications are for third-line therapy or later.
“Patients with aggressive B-cell non-Hodgkin lymphoma who are refractory to first-line treatment are vulnerable, and we are disappointed that the BELINDA study did not meet its primary endpoint in this setting,” Jeff Legos, PhD, MBA, executive vice president and global head of oncology and hematology development for Novartis, said in the release.
“Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting,” Legos added. “We remain committed to accelerating development of Kymriah and our next-generation CAR-Ts and anticipate sharing early clinical results for these therapies at an upcoming medical meeting.”
Click Here to Manage Email Alerts