Bristol Myers Squibb (BMY) announced Thursday positive topline results from Phase 3 TRANSFORM trial evaluating Breyanzi (lisocabtagene maraleucel) versus chemotherapy followed by stem cell transplant in second-line relapsed or refractory large B-cell lymphoma or LBCL.
The trial met primary and key secondary endpoints, demonstrating a highly statistically significant improvement in event-free survival, complete response rate and progression-free survival compared to standard of care. Overall survival data were immature at the time of this interim analysis, the company noted.
TRANSFORM global, randomized, multicenter Phase 3 study evaluates Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory 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.
The trial's 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.
Breyanzi safety results are consistent with data from pivotal TRANSCEND NHL 001 trial.
The company noted that the latest 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. It is also the first time a CD19-directed CAR T cell therapy has demonstrated potential as a second-line therapy in this patient population.
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