Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease or have relapsed within 12 months of receiving first-line treatment.
Bristol Myers Squibb received FDA approval for Breyanzi as third-line therapy in February.
FDA granted accelerated approval to Yescarta for relapsed or refractory follicular lymphoma in March.
The standard of care in the treatment was salvage chemotherapy. Also known as rescue therapy, salvage chemotherapy involves a therapy administered after a disease fails to respond to standard therapy. Patients who responded to salvage therapy received high-dose chemotherapy and stem cell transplant.
While Novartis is disappointed in the results, Kymriah “continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting,” said Jeff Legos, executive vice president, global head of oncology & hematology development at Novartis, in a statement. “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.”
Kymriah is currently FDA indicated for patients aged three to 25 with B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse. It is also indicated for adults with relapsed or refractory large B-cell lymphoma who have received at least two lines of systemic therapy.
Filed Under: clinical trials, Drug Discovery, Oncology