Benzinga | Jun 10, 2021 07:00AM EDT

Bristol Myers Squibb Announces Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma Met The Primary Endpoint

Study 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

Breyanzi safety results consistent with data from pivotal TRANSCEND NHL 001 trial

Results represent the first time a therapy has demonstrated benefit compared to high-dose chemotherapy and stem cell transplant in relapsed or refractory large B-cell lymphoma, and support the potential of Breyanzi in earlier lines of therapy in this patient population

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced positive topline results from TRANSFORM, a global, randomized, multicenter Phase 3 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.

"We ambitiously designed the TRANSFORM trial to evaluate Breyanzi's potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard of care regimen of high-dose chemotherapy and autologous stem cell transplant," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology and Cell Therapy Development, Bristol Myers Squibb. "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."

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.

Breyanzi, a CD19-directed CAR T cell therapy, 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. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding cytokine release syndrome and neurotoxicity.