Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improved progression-free survival and a well-established safety profile with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity

This is the first positive CHMP opinion in earlier lines of therapy for a chimeric antigen receptor (CAR) T cell therapy in the treatment of relapsed and refractory multiple myeloma

Approval by the European Commission would expand Abecma’s indication, making it the first CAR T cell therapy available in the European Union (EU) for patients with triple-class exposed relapsed and refractory multiple myeloma earlier in the treatment journey

Excerpt from the Press Release:

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization approval of Abecma^® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, M.D., senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “We look forward to working with the European Commission with the shared goal of delivering innovative treatment options to more patients with continued unmet need.”

The CHMP adopted a positive opinion based on the final progression-free survival (PFS) analysis from the pivotal, Phase 3, open-label, global, randomized, controlled KarMMa-3 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 IMiD, a PI, and an anti-CD38 monoclonal antibody, which are the three main classes of therapy (triple-class exposed) in multiple myeloma, and who were refractory to their last regimen. Results recently presented at the American Society of Hematology (ASH) Annual Meeting in December 2023 showed, at a median follow-up of 30.9 months (range: 12.7-47.8), Abecma significantly improved PFS compared with standard regimens, with a median PFS of 13.8 months vs. 4.4 months (HR:0.49; 95% CI: 0.38-0.63), representing a 51% reduction in the risk of disease progression or death with Abecma.

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