Bristol Myers Squibb, a member of Bio Nebraska, announced that 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.
Announcement by Bristol Myers Squibb
Bristol Myers Squibb 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.