Promising results from BMS’s TRANSCEND clinical trials in FL and MCL presented at ICML 2023

CAR-T Digest - August 2020

Weekly Digest - 17-23 Jun 2023

17 Jun 2023: Breyanzi / Follicular Lymphoma / Mantle Cell Lymphoma / BMS: TRANSCEND clinical trials delivered deep and durable responses

BMS announced the initial disclosure of the primary analysis results of Breyanzi from two pivotal studies, TRANSCEND FL and TRANSCEND NHL 001
Results from Phase 2 TRANSCEND FL trial
- Efficacy: (n = 101; 3L+)
  - ORR: 97%; CR: 94%
  - 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 PFS was also not reached at a median follow-up of 17.5 months
  - 12-month PFS achieved in 80.7% of patients
- Safety: (n = 130; 2L+)
  - No new safety signals observed and low rates of severe cytokine release syndrome (CRS) and neurologic events (NE)
  - Any grade CRS: 58%; Grade 3 CRS: 1%; no Grade 4/5 CRS reported
  - Any grade NEs: 15%; Grade 3 NEs: 2%; no Grade 4/5 NEs reported
Results from Phase 2 TRANSCEND NHL 001 trial:
- Efficacy: (n = 74; 2L+); dose: either 50 x 106 or 100 x 106 CAR-positive viable T cells
  - median follow-up: 16.1 months
  - ORR: 86.5%
  - CR: 74.3%
- Safety: (n = 88)
  - Breyanzi was well-tolerated and no new safety signals were observed
  - Any grade CRS: 61%; Grade 3/4 CRS: 1%; no Grade 5 CRS reported
  - Any grade Nes: 31%; Grade 3/4 NEs: 9%; no Grade 5 NEs reported
“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.” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb