Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating a significant overall response rate (ORR).
Study Highlights
- Primary Endpoint: Breyanzi achieved a statistically significant ORR in MZL patients, marking progress in treating this hard-to-treat subgroup.
- Mechanism: The therapy uses a 4-1BB costimulatory domain to enhance CAR T cell expansion and persistence, improving efficacy.
Drug Profile
Breyanzi is an autologous CAR T cell therapy approved in the U.S. for:
- Relapsed/refractory large B-cell lymphoma (LBCL) after ≥1 prior therapy.
- Relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.
- Relapsed/refractory follicular lymphoma (FL) after ≥2 systemic therapies.
- Relapsed/refractory mantle cell lymphoma (MCL) after ≥2 systemic therapies, including a BTK inhibitor.
Global Approvals
- Japan/Europe: Approved for second-line LBCL and relapsed/refractory LBCL after ≥2 therapies.
- Switzerland/Canada: Approved for LBCL after ≥2 therapies.
- Japan: Approved for high-risk FL after 1 prior therapy and for relapsed/refractory patients after ≥2 therapies.
Strategic Outlook
The TRANSCEND FL results strengthen Breyanzi’s position in hematologic malignancies. BMS plans to leverage the data to expand indications and reinforce its CAR T cell therapy pipeline.-Fineline Info & Tech
