BMY Reports Positive Results From Phase 3 Breyanzi Trial In Second-line Relapsed Or Refractory LBCL

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.

Noah Berkowitz, senior vice president, Hematology and Cell Therapy Development, Bristol Myers Squibb, said, "These positive interim results build on our commitment to bring CAR T cell therapies into earlier lines and highlight the potential of Breyanzi to transform the treatment paradigm for this difficult-to-treat disease, possibly supplanting the need for patients to undergo current aggressive treatment regimens."

Bristol Myers Squibb will complete an evaluation of the TRANSFORM data, and plans to share the results at an upcoming medical conference, as well as with health authorities.

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