Bristol-Myers says lisocabtagene maraleucel study met both endpoints
Bristol-Myers Squibb announced the pivotal study of lisocabtagene maraleucel, an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells in relapsed/refractory large B-cell lymphomas met its primary and secondary endpoints while demonstrating durable responses. In the study, 344 patients were leukapheresed and 269 patients received liso-cel at one of three dose levels. There were 25 patients that received nonconforming product and there were two instances where product could not be manufactured. Patients were heavily pretreated and had aggressive disease with a median of three prior therapies including 35% with prior autologous or allogeneic hematopoietic stem cell transplant and 67% with chemotherapy-refractory disease. Bridging therapy was administered to 59% of patients. Among patients evaluable for efficacy, the overall response rate was 73% with 53% of patients achieving a complete response. Responses were similar across all patient subgroups, the company added. The median duration of response for all patients was not reached at a median follow-up of 12 months. Median progression-free survival was 6.8 months and median overall survival was 21.1 months. The median PFS and OS for patients who achieved a CR was not reached with 65.1% of patients progression free and 85.5% of patients alive at 12 months, respectively, Bristol added.