Bristol Myers Squibb’s CAR-T Therapy Breyanzi Demonstrates Superiority Over Standard Second-Line Treatment in Phase 3 TRANSFORM Trial

Bristol-Myers Squibb Company (BMS) announced today that its CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) met the primary and key secondary endpoints in a Phase 3 clinical trial, significantly improving event-free survival, complete response rate, and progression-free survival compared with standard therapy in patients with relapsed/refractory large B-cell lymphoma (LBCL). The press release noted that this is the first therapy to demonstrate clinical benefits compared with standard second-line therapy in this patient population.

Breyanzi is an autologous CAR-T cell therapy targeting the CD19 antigen, approved by the U.S. FDA in February 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) who have received two or more prior lines of systemic therapy. A unique feature of this therapy is the controlled ratio of CD8+ and CD4+ T cells within the CAR-T cell product, thereby enabling better management of the therapy's toxicity.

The randomized, double-blind, pivotal Phase 3 clinical trial named TRANSFORM was conducted in adult patients with large B-cell lymphoma who relapsed within 12 months of initial therapy. The trial evaluated the efficacy of Breyanzi compared with the current standard of care (including high-dose chemotherapy and hematopoietic stem cell transplantation). The study met its primary endpoint, demonstrating a clinically and statistically significant improvement in event-free survival compared with standard of care. Breyanzi also met key secondary endpoints for improvements in complete response rate and progression-free survival. The safety profile was consistent with findings from prior studies.

Note: The original text has been abridged.

References:

[1] Bristol Myers Squibb Announces 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. June 10, 2021, from https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-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/default.aspx

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