Bristol-Myers, 2seventy Bio present results from KarMMa-3 studyof Abecma

Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) announced the first publication and presentation of results from KarMMa-3, a pivotal Phase 3, open-label, global, randomized, controlled study evaluating Abecma compared with standard combination regimens in adults with relapsed 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, and who were refractory to their last regimen. Data from KarMMa-3 are being published in The New England Journal of Medicine and simultaneously presented at the EBMT and the European Hematology Association’s 5th European CAR T-cell Meeting on Friday, February 10 in an oral presentation during the Best Abstract Session. At a median follow up of 18.6 months, treatment with Abecma demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival compared with standard regimens, with a median PFS of 13.3 months vs. 4.4 months, respectively. This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. Results for the key secondary endpoint of overall response rate also met statistical significance with the majority of patients treated with Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In comparison, less than half of patients who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. Responses with Abecma were durable with a median duration of 14.8 months compared with 9.7 months for standard regimens. Clinical benefit with Abecma was consistently observed across difficult-to-treat subgroups. Abecma exhibited a consistent and generally predictable safety profile, including no new safety signals, with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity. In patients treated with Abecma, 88% experienced any grade CRS, with Grade 3/4 events occurring in 4% of patients. Two patients experienced a Grade 5 CRS event. Median time to onset of CRS was 1 day and median duration of CRS was 3.5 days. Any grade neurotoxicity occurred in 15% of patients, with Grade 3/4 neurotoxicity occurring in 3% of patients, and no Grade 5 events reported. Median time to onset of neurotoxicity was 3 days and median duration of neurotoxicity was 2 days. Bristol Myers Squibb and 2seventy bio intend to include these data in a planned supplemental Biologics License Application submission to the U.S. Food and Drug Administration in 2023.