Idecabtagene vicleucel prolonged progression-free survival by more than 1 year in a difficult-to-treat patient population with relapsed or refractory multiple myeloma.
Idecabtagene vicleucel (Abecma; Bristol Myers Squibb) displayed a clinically meaningful and statistically significant improvement in progression-free survival (PFS) compared with standard regimens in adults with relapsed or refractory multiple myeloma, according to a study published in a paper in The New England Journal of Medicine.
Investigators evaluated idecabtagene vicleucel against standard treatment regimens in the phase 3, open-label, global, randomized, controlled KarMMa-3 trial, for patients with previous immunomodulatory treatment who are also refractory. The primary endpoint of KarMMa-3 was PFS from randomization until disease progression or any-cause death. The secondary endpoints were overall response rate (ORR) and overall survival (OS).
Patients enrolled in the trial were previously administered 2 to 4 lines of therapy with an immunomodulatory agent (proteasome inhibitor, and/or an anti-CD38 monoclonal antibody) and are refractory to the most recent regimen.
Idecabtagene vicleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy, improved median PFS by 8.9 months compared to the standard regimen. It further demonstrated a 51% improvement in the risk of disease progression or death.
Idecabtagene vicleucel is the only CAR T-cell therapy that is superior to standard treatment in this clinical setting, according to the study investigators.
“The KarMMa-3 study is the first with a BCMA-directed CAR T therapy to demonstrate superiority versus standard regimens for patients with relapsed and refractory multiple myeloma, illustrating the potential of idecabtagene vicleucel to change the standard of care of triple-class exposed multiple myeloma in early lines,” said Steve Bernstein, MD, chief medical officer, 2seventy bio, in a press release.
Among participants, 71% had a significant ORR compared to 41% on standard regimens.
Idecabtagene vicleucel increased median response to 14.8 months compared to 9.7 months. PFS was 13.3 months in the idecabtagene vicleucel arm compared to 4.4 months in the control arm.
“With idecabtagene vicleucel, our first-in-class anti-BCMA CAR T cell therapy, we sought to deliver a personalized therapy that provides durable outcomes with a single infusion to advance the multiple myeloma treatment paradigm for patients,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb, in the press release.
The most common adverse event (AE) was cytokine release syndrome, which occurred in 88% of patients treated with idecabtagene vicleucel and lasted for a median of 3.5 days. At least 15% of patients also experienced any grade of neurotoxicity. The median duration was 2 days and no grade 5 AEs occurred.
Findings from KarMMa-3 were also presented in an oral presentation at the 5th European CAR T-cell Meeting (European Hematology Association) on February 10, 2023.
“These results from KarMMa-3 introduce the potential for this anti-BCMA CAR T cell therapy to become a standard of care earlier in the treatment course for relapsed and refractory multiple myeloma,” said Sergio Giralt, MD, Division of Hematologic Malignancies, Memorial Sloan Kettering Cancer Center, in the press release.
Bristol Myers Squibb. Abecma (idecabtagene vicleucel) Reduced the Risk of Disease Progression or Death by 51% Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Results from Phase 3 KarMMa-3 Study. News Release. February 10, 2023. Accessed on February 13, 2023. https://news.bms.com/news/corporate-financial/2023/Abecma-idecabtagene-vicleucel-Reduced-the-Risk-of-Disease-Progression-or-Death-by-51-Versus-Standard-Regimens-in-Earlier-Lines-of-Therapy-for-Relapsed-and-Refractory-Multiple-Myeloma-Based-on-Results-from-Phase-3-KarMMa-3-Study/default.aspx