Bristol-Myers reports ‘positive’ results from TRANSCEND studies

Bristol Myers Squibb announced positive topline results from two studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma, 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. 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. 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.