Bristol Myers Squibb announced that Breyanzi (lisocabtagene maraleucel) was approved by the U.S. Food and Drug Administration (FDA) for treating adult patients with refractory or relapsed patients with large B-cell lymphoma (LBCL). Breyanzi is approved for diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.
The approval was based on the Phase 3 TRANSFORM trial and Phase 2 PILOT study. In the Phase 3 TRANSFORM trial, adult patients with LBCL were relapsed or refractory within 12 months of front-line therapy. They were randomized to either Breyanzi or standard of care (including salvage chemotherapy and high-dose chemotherapy or HSCT if patients have responses). The event-free survival was four times higher than the standard of care (10.1 months vs. 2.3 months). 66% of patients achieved complete response versus 39% on standard of care. The progression-free survival was 14.8 months versus 5.7 months in patients on standard of care.
In the Phase 2 PILOT study, patients who were not the candidates for stem cell transplant were included. Breyanzi demonstrated an overall response of 80% and a complete response of 54%.
BMS announced that Breyanzi had a well-established safety profile; grade 3 CRS was reported in only 1.3% of patients.
With this approval, BMS announced that Breyanzi has the widest population for CAR T therapy in patients with LBCL. Further, Breyanzi was not approved for primary central nervous system lymphoma.