SOC cilta-cel evaluated for relapsed/refractory multiple myeloma
Sidana S, Patel KK, Peres LC, et al. Safety and Efficacy of Standard of Care Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma. Blood. 2024; (doi: 10.1182/blood.2024025945).
Evidence suggests ciltacabtagene autoleucel (cilta-cel) generates a durable response in patients with relapsed/refractory multiple myeloma, even those who would not have qualified for participation in the clinical study underpinning its approval. FDA cleared the chimeric antigen receptor (CAR) T-cell therapy in 2022 based on results from the CARTITUDE-1 trial. In a new, multicenter study, 255 patients underwent leukapheresis for cilta-cel manufacturing; 56% of the patients would not have met CARTITUDE-1 inclusion criteria. With an overall manufacturing failure rate of just 1%, 236 of the 255 patients ultimately went on to receive cilta-cel. Best overall response (OR) rates and complete response (CR) rates were 89% and 70%, respectively, for the sample as a whole. The OR and CR rates were even better in the subgroups of patients who received conforming CAR-T product (94% and 74%, respectively) or conforming CAR-T product with fludarabine/cyclophosphamide lymphodepletion (95% and 76%, respectively). Non-relapse mortality was 10%, primarily due to infection, while the median progression-free survival was estimated at 68% at 12 months. The results support a standard-of-care application for cilta-cel, though investigators emphasize the importance of mitigating delayed neurotoxicity and non-relapse mortality and of closely monitoring patients for late-onset complications.