Bristol Myers Squibb’s TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi (lisocabtagene maraleucel)in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma Meet Primary Endpoint of Overall Response Rate
Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from two studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel) in patients with relapsed or refractory follicular lymphoma (FL), and TRANSCEND NHL 001, an open-label, multicenter, pivotal Phase 1, single-arm study evaluating Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma (MCL). Results showed both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and clinically meaningful responses in relapsed or refractory FL and MCL.
The studies also met the key secondary endpoint of complete response rate, demonstrating high rates of complete responses in both relapsed or refractory FL and MCL. No new safety signals were reported for Breyanzi in either disease in these studies.
“For people living with relapsed or refractory follicular lymphoma or mantle cell lymphoma, there are limited treatment options that provide deep and durable responses, especially for patients with high-risk disease,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “These continued unmet needs coupled with our deep understanding of lymphoma biology drive us to deliver transformative treatments for patients. We believe these data further confirm Breyanzi’s best-in-class and best-in-disease profile, and underscore the significant progress we are making in bringing the promise of our differentiated CAR T cell therapy, Breyanzi, to more patients.”
Bristol Myers Squibb will complete a full evaluation of the TRANSCEND FL and TRANSCEND NHL 001 data, and work with investigators to present detailed results from the two studies at an upcoming medical meeting, as well as discuss these results with health authorities. Bristol Myers Squibb also recently announced that the TRANSCEND CLL 004 trial of Breyanzi in relapsed or refractory chronic lymphocytic leukemia met the primary endpoint of complete response rate. Bristol Myers Squibb thanks the patients and investigators who are participating in the TRANSCEND clinical trials.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.