In TRANSCEND FL, 97% of patients with relapsed or refractory follicular lymphoma treated with Breyanzi achieved a response, with 94% achieving a complete response, and 81.9% of responders in ongoing response at 12 months

In TRANSCEND NHL 001, 86.5% of patients in the relapsed or refractory mantle cell lymphoma cohort achieved a response, with 74.3% achieving a complete response

Breyanzi showed a manageable safety profile, with no new safety signals and low rates of severe cytokine release syndrome and neurologic events in both studies

Results from TRANSCEND FL and TRANSCEND NHL 001 further underscore Breyanzi’s potential best-in-class and best-in-disease profile for a CD19-directed CAR T cell therapy in lymphomas

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory follicular lymphoma (FL) and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. These data were presented in late-breaking oral presentations at the 2023 International Conference on Malignant Lymphoma (ICML) on Saturday, June 17.

“With Breyanzi, we’re dedicated to delivering a CAR T cell therapy with a differentiated profile to transform outcomes for some of the most difficult-to-treat lymphomas,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “Based on results from TRANSCEND FL and TRANSCEND NHL 001, Breyanzi continues to demonstrate the ability to elicit significant deep and durable responses alongside a manageable safety profile, potentially addressing areas of high unmet need and reinforcing our commitment to advancing innovative solutions for the broadest array of hematologic malignancies of any CD19-directed CAR T cell therapy.”

Results from the TRANSCEND FL and TRANSCEND NHL 001 studies will be discussed with health authorities. Bristol Myers Squibb thanks the patients and investigators involved in the TRANSCEND clinical trials.

Results from TRANSCEND FL

TRANSCEND FL, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL, enrolled adults with relapsed or refractory disease treated with Breyanzi in the second-line and third-line plus setting. Patients received treatment with Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells.

In efficacy evaluable patients with relapsed or refractory FL treated with Breyanzi in the third-line plus setting (n=101), the overall response rate (ORR) was 97% (95% CI: 91.6-99.4; one-sided p