Bristol-Myers Squibb announced positive topline results from the phase 3 global, randomized, multicenter TRANSFORM study. The evaluated Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant, which is currently considered standard treatment for these patients. Results of a pre-specified interim analysis conducted by an independent review committee showed the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care. Overall survival data were immature at the time of this interim analysis. No new safety concerns were identified in this second-line setting.
The company plans to fully evaluate the TRANSFORM data and will share the results at an upcoming medical conference, as well as with health authorities.
About Breyanzi (lisocabtagene maraleucel)
Breyanzi (lisocabtagene maraleucel) is a CD19-directed CAR T cell therapy.
Breyanzi was approved by the U.S. Food and Drug Administration (FDA) in February 2021 for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.