Cilta-cel in lenalidomide-refractory multiple myeloma: updated analysis including overall survival from the multinational phase 3 CARTITUDE-4 trial

In the multinational phase 3 CARTITUDE-4 trial, a single infusion of ciltacabtagene autoleucel (cilta-cel) significantly prolonged progression-free survival (PFS) in patients with lenalidomide-refractory multiple myeloma (MM). Updated analysis including overall survival (OS) has now been published. The trial recruited 419 patients with MM after one to three previous treatment lines, and an ECOG performance status 0 or 1. Patients were randomized to receive cilta-cel (n=208) or standard of care (n=211). At a median follow-up or 33.6 months (IQR 20.3-35.0), median PFS was not reached in the cilta-cel groups versus 11.8 months in the standard-of-care group (HR 0.29; 95% CI 0.22-0.39), and median OS was not reached in the cilta-cel group versus not reached with standard of care (0.55; 0.39-0.79). Maximum grade 3 treatment-emergent adverse events were reported for 14% of patients with cilta-cel and 37% of patients with standard of care; maximum grade 4 TRAEs were reported in 75% and 56%, deaths occurred in 24% and 39%, including due to TRAEs in 3% and 2%, respectively. The authors conclude that these findings support the use of cilta-cel in treating relapsed or refractory MM as early as after first relapse.