Aug 24, 2021: “Novartis announced an update on the Phase III BELINDA study investigating Kymriah® (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.
About the BELINDA study
The BELINDA study is a pivotal Phase III, randomized, open label, multicenter trial comparing two treatment strategies and assessing the efficacy, safety, and tolerability of Kymriah (tisagenlecleucel) compared to standard-of-care (SOC).
Patients in the trial had aggressive B-cell non-Hodgkin lymphoma with primary refractory disease, or which relapsed within 12 months of first-line treatment.
SOC was salvage chemotherapy followed in responding patients by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT).
This international trial enrolled patients from over 73 sites in 18 countries worldwide.
The primary endpoint was event-free survival (EFS) defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 assessment, per blinded independent review committee (BIRC), or death at any time.
Secondary endpoints include EFS as assessed by local investigator, overall survival, overall response rate, duration of response, time to response and safety.
Patients in the control arm, receiving SOC, had the opportunity to cross over to receive Kymriah upon progression determined by BIRC.”