Study of ide-cel in R/R MM patients ineligible for KarMMa-1
Dima D, Rashid A, Davis JA, et al. Efficacy and Safety of Idecabtagene Vicleucel in Patients With Relapsed-Refractory Multiple Myeloma Not Meeting the KarMMa-1 Trial Eligibility Criteria: A Real-World Multicentre Study. British Journal of Haematology. 2024; (doi: 10.1111/bjh.19302).
A real-world investigation provides the rationale for enrolling more diverse populations in future clinical trials evaluating idecabtagene vicleucel (ide-cel). The chimeric antigen receptor T-cell therapy received FDA approval for the treatment of relapsed-refractory multiple myeloma (RRMM) in 2021. Clearance was based on the pivotal KarMMa-1 study, which disqualified patients with comorbidities from participating, along with individuals who had aggressive disease, poor performance, or prior exposure to B-cell maturation antigen-directed therapy (BCMA-DT). A retrospective analysis examined outcomes in 69 patients who were ineligible for KarMMa-1 but received standard of care (SOC) ide-cel. Researchers discovered that rates of adverse events including cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, early or severe infection, high-grade cytopenia, anemia, and thrombocytopenia were not remarkably different from those reported in KarMMa-1. Meanwhile, the overall response rate and the complete response or better rate were both higher for the SOC patients than for the study cohort, at 93% vs. 73% and 48% vs. 33%, respectively. Rates of median progression-free survival and overall survival were similar between the two groups. With a tolerable safety profile in line with that of the KarMMa-1 trial population, the findings suggest ide-cel may be a feasible option for even R/R MM patients who are frail, have multiple comorbidities, or previously underwent BCMA-DT.