Results from pivotal phase II KarMMa study of idecabtagene vicleucel to treat refractory multiple myeloma were published in NEJM. - bluebird bio + BMS

Results from the pivotal Phase II KarMMa study evaluating the efficacy and safety of bluebird bio, Inc. and Bristol Myers Squibb’s investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, idecabtagene vicleucel (ide-cel; bb2121), in adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, were published in The New England Journal of Medicine. The KarMMa study met its primary endpoint of overall response rate and key secondary endpoint of complete response rate. The data from the study demonstrates deep and durable responses with ide-cel treatment in triple-class exposed RRMM patients (n=128). Clinically meaningful responses were reported in heavily pre-treated patients across all dose levels and in multiple high-risk subgroups, including those with high-risk cytogenetics, triple- or penta-refractory disease, high tumor burden at baseline, and extramedullary disease. Clinically meaningful improvement was also observed across measures for median duration of response, median progression-free survival and overall survival in treated patients.. See- Munshi NC, Anderson LD, Shah N, et al. "Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma ". N Engl J Med. 2021 February 25;384:705-716..