Phase III TRANSFORM study of Breyanzi meets primary endpoint in large B-cell lymphoma – BMS

Bristol Myers Squibb announced positive topline results from TRANSFORM, a global, randomized, multicenter Phase III study evaluating 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 a gold 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. Safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting, and no new safety concerns were identified in this second-line setting.

The results represent the first time a therapy has shown a benefit over standard of care high-dose chemotherapy and stem cell transplant in relapsed or refractory LBCL, and the first time a CD19-directed CAR T cell therapy has demonstrated potential as a second-line therapy in this patient population. The company will complete an evaluation of the TRANSFORM data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the TRANSFORM clinical trial.