Bristol Myers, 2seventy Bio announce result from KarMMa-3 Ph3 trial of Abecma

Bristol Myers (BMY) and 2seventy bio (TSVT) “announced results from the preplanned final progression-free survival analysis of KarMMa-3, the pivotal Phase 3, open-label, global, randomized controlled study evaluating Abecma compared with standard combination regimens in adults with rel apsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, who were refractory to their last regimen. At a median follow-up of 30.9 months, representing the longest follow-up for a randomized Phase 3 CAR T cell therapy trial in this patient population, significantly improved PFS was maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death. These data are being presented today in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. With extended follow-up, treatment with Abecma continued to demonstrate higher overall response rates and a deepening of responses versus standard regimens. The ORR with Abecma was 71% with a complete response (CR) rate of 44% (95% CI: 38-50), which increased by 5% from the interim analysis. In comparison, the ORR for standard regimens was 41% (95% CI: 34-51), with a CR rate of 5% (95% CI: 2-9), which remained unchanged from the time of interim analysis. The PFS, ORR and CR rates observed in the KarMMa-3 trial in the standard regimens arm are consistent with those that have historically been observed in this heavily pre-treated triple-class exposed patient population, in which PFS is approximately four months and deep and durable responses are limited. With these data, Abecma is the first and only anti-BCMA CAR T cell therapy to demonstrate superiority over standard regimens in a randomized, controlled Phase 3 trial designed to evaluate patients with triple-class exposed relapsed and refractory multiple myeloma.”