Bristol-Myers announces primary analysis results from TRANSCEND trials

Bristol Myers Squibb 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 in patients with relapsed or refractory follicular lymphoma and the relapsed or refractory mantle cell lymphoma cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. 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, the overall response rate was 97%, with 94% of patients achieving a complete response. Responses were durable with a median duration of response not reached at a median follow-up of 16.6 months. At 12 months, 81.9% of responders had an ongoing response. Median progression-free survival was also not reached at a median follow-up of 17.5 months, with 12-month PFS achieved in 80.7% of patients. With a median on-study follow-up of 18.9 months in the safety set, which included patients treated in the second-line plus setting, Breyanzi exhibited a manageable safety profile, with no new safety signals observed and low rates of severe cytokine release syndrome and neurologic events. Any grade CRS occurred in 58% of patients, with Grade 3 CRS occurring in 1% of patients and no Grade 4/5 CRS reported. Any grade NEs were reported in 15% of patients, with Grade 3 NEs occurring in 2% of patients and no Grade 4/5 NEs reported. Historically, outcomes are poor for patients with relapsed or refractory FL. Despite high initial response rates to front-line treatment, the majority of patients experience multiple relapses and prognosis often worsens with subsequent relapses. Additionally, the durability of response with available treatment options decreases with each subsequent line of therapy. There are currently no curative options. The MCL cohort of TRANSCEND NHL 001 enrolled adults with relapsed or refractory disease after two or more prior lines of therapy, including a BTK inhibitor. These patients were treated with Breyanzi at dose levels of either 50 x 106 or 100 x 106 CAR-positive viable T cells. With a median on-study follow-up of 16.1 months, the ORR in patients evaluated for efficacy in the primary analysis set was 86.5%, with 74.3% of patients achieving a CR. In the safety set, Breyanzi was well-tolerated and no new safety signals were observed. Any grade CRS occurred in 61% of patients, with Grade 3/4 CRS occurring in 1% of patients and no Grade 5 CRS reported. Any grade NEs were reported in 31% of patients, with Grade 3/4 NEs occurring in 9% of patients and no Grade 5 NEs reported.