Bristol Myers discloses results from second-line cohort of TRANSCEND FL study

Bristol Myers announced the first disclosure of primary analysis results from the high-risk, second-line cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma, or FL. TRANSCEND FL is 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. Additionally, the company presented long-term data from the TRANSCEND CLL 004 study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, or small lymphocytic leukemia, or SLL, with 24-month follow-up. These data are being featured in oral presentations at the 2023 American Society of Hematology, or ASH, Annual Meeting, from December 9-12, with the TRANSCEND FL 2L oral presentation selected as part of the 2024 Highlights of ASH for lymphoma. Results from TRANSCEND FL will be discussed with health authorities. A supplemental biologics license application for Breyanzi in relapsed or refractory CLL based on results from TRANSCEND CLL 004 is currently under review by the FDA with a target action date of March 14, 2024. Bristol Myers has the broadest ongoing cell therapy development program in CD19-positive malignancies with Breyanzi, which also includes trials investigating its use in patients with relapsed/refractory mantle cell lymphoma, or MCL. Results from the primary analysis of the MCL cohort of TRANSCEND NHL 001 were simultaneously published in Journal of Clinical Oncology. In the TRANSCEND FL clinical trial, 130 patients with relapsed or refractory follicular lymphoma, or FL, were enrolled and treated with Breyanzi in the second-line and third-line plus settings. Patients received treatment with Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells. TRANSCEND FL is the largest clinical trial evaluating a CAR T cell therapy in relapsed or refractory FL, and the first trial to report outcomes for a CAR T in second-line, high-risk FL, with results generally consistent with the efficacy and safety results observed in third-line FL. In patients with high-risk relapsed or refractory FL treated with Breyanzi in the second-line setting who were evaluable for efficacy with a median on-study follow-up of 18.1 months, Breyanzi elicited significant responses in nearly all patients, with all responders achieving a complete response, or CR. The overall response rate, or ORR, the study’s primary endpoint, and CR rate were 95.7%. With a median follow-up of 16.8 months, median duration of response, or DOR, was not reached. The probability of patients remaining in response at 12 months was 89.8%. Median progression-free survival, or PFS, was also not reached, with a PFS rate of 91.3% at 12 months. Breyanzi continued to exhibit a manageable and predictable safety profile with no new safety signals observed and low rates of severe cytokine release syndrome, or CRS, and neurologic events, or NE. Any-grade CRS occurred in 52.2% of patients, with no grade greater than CRS reported. Any-grade NEs were reported in 17.4% of patients, with Grade 3 NEs occurring in 4.3% of patients and no Grade 4/5 NEs reported. All cases of CRS and NEs were managed to resolution. Patient-reported outcomes, or PROs, from TRANSCEND FL are also being presented, representing the first disclosure of PRO data for a CAR T cell therapy in relapsed or refractory FL. Based on an exploratory analysis, the majority of patients with second- or third-line relapsed or refractory FL reported clinically significant improvements in quality of life, disease symptoms, and functioning after being treated with Breyanzi. Those receiving Breyanzi in the second-line setting generally demonstrated greater and faster meaningful improvements in most primary domains, compared to those who received Breyanzi in the third-line setting, including role and cognitive functioning, fatigue, pain, and Functional Assessment of Cancer Therapy Lymphoma scores. Results from the third-line-plus treatment cohort of TRANSCEND FL were previously presented at the 2023 International Conference on Malignant Lymphoma in June.