Bristol Myers presents data from Phase 2 trial of Breyanzi

Bristol Myers (BMY) Squibb announced the first disclosure of the primary analysis results of the marginal zone lymphoma cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory disease. The new data will be presented at the 2025 International Conference on Malignant Lymphoma in an oral presentation on June 19, building on positive topline results announced in February. “Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” said M. Lia Palomba, M.D., TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is 3 to 5 years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.” The MZL cohort of TRANSCEND FL enrolled adults with relapsed or refractory disease treated with liso-cel in the third-line plus setting. Patients received treatment with liso-cel at a target dose of 100 x 106 CAR-positive viable T cells. In efficacy-evaluable patients with relapsed or refractory MZL treated with liso-cel, liso-cel demonstrated clinically meaningful benefit, with high rates of durable responses. The overall response rate was 95.5%, with 62.1% of patients achieving a complete response by independent review committee per CT. With a median follow-up of 21.6, 23.8, and 24.5 months, respectively, the 24-month rates were 88.6% for duration of response, 85.7% for progression-free survival, and 90.4% for overall survival. Liso-cel exhibited a consistent safety profile, with low rates of severe cytokine release syndrome and neurologic events with no new safety signals observed. Any grade CRS occurred in 76% of patients, with Grade 3 CRS occurring in 4% of patients and no Grade 4/5 CRS reported. Any grade NEs were reported in 33% of patients, with Grade 3 NEs occurring in 4% of patients and no Grade 4/5 NEs reported. The study will continue to evaluate ORR and safety in patients through the final analysis.