Benzinga | Aug 24, 2021 05:05AM EDT

Novartis Announced Phase III BELINDA Study Did Not Meet Primary Endpoint of Event-free Survival for Patients With Aggressive B-cell Non-hodgkin Lymphoma Who Had Primary Refractory Disease or Who Relapsed Within 12 Months of First-line Treatment

Novartis (NYSE:NVS) today announced an update on the Phase III BELINDA study investigating Kymriah(r) (tisagenlecleucel) in aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment. The BELINDA study did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC). SOC was salvage chemotherapy followed in responding patients by high-dose chemotherapy and stem cell transplant. The safety profile was consistent with the established safety profile of Kymriah. Novartis will complete a full evaluation of the BELINDA data and work with investigators on the future presentation of the results.

"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," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting. 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."

"We were hopeful the BELINDA study would show that Kymriah could improve outcomes and the overall treatment experience for these patients in need. The study investigators will work together with Novartis in the coming weeks and months to understand the factors that contributed to this outcome," said Michael R. Bishop, MD, Professor of Medicine and Director of the Hematopoietic Stem Cell Transplantation Program, University of Chicago Medicine and BELINDA Steering Committee Chair.

Novartis is grateful to the patients, families and investigators who participated in this trial for their determination to contribute to advancing the treatment of this aggressive blood cancer.