Novartis provides update on BELINDA study investigating Kymriah? as second-line treatment in aggressive B-cell non-Hodgkin lymphoma
Basel, August 24, 2021?? Novartis today 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.
About Novartis Commitment to Oncology Cell & Gene
Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of the Novartis commitment to CAR-T cell therapy.
Kymriah is currently approved for the treatment of relapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL). Kymriah is available in 30 countries and 330 certified treatment centers, with the ambition for further expansion.
The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents and includes both Novartis-owned and contract manufacturing sites. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain.
US FDA approved indication for Kymriah
Kymriah??(tisagenlecleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which is indicated for:
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- The treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
- The treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma (FL).?Limitations of Use:?Kymriah is not indicated for treatment of patients with primary central nervous system lymphoma.
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Novartis Media Relations E-mail:?media.relations@novartis.comAnja von Treskow Novartis External Communications +41 61 324 2279 (direct) +41 79 392 8697 (mobile) anja.von_treskow@novartis.com Julie Masow Novartis US External Communications +1 862 579 8456 Julie.masow@novartis.com | Fiona Phillips Novartis Oncology Communications +1 862 217 9396 fiona.phillips@novartis.com |
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