Ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T delivers durable 30-month PFS/OS—even in high-risk cytogenetics with ≥PR bridging response

Ciltacabtagene autoleucel (cilta-cel) is an autologous anti-BCMA CAR-T cell therapy evaluated in CARTITUDE-4 (Phase 3; NCT04181827) for lenalidomide-refractory multiple myeloma after 1–3 prior lines; this as-treated subgroup analysis focused on patients who achieved ≥PR to bridging therapy (BT) before cilta-cel infusion. With median follow-up 33.6 months, outcomes were strong in both cytogenetic strata: high-risk (del(17p), t(4;14), t(14;16), gain/amp(1q); n=64) had 30-month PFS 65.1% and OS 87.2% (medians not reached), while standard-risk (n=40) had 30-month PFS 85.0% and OS 92.5% (medians not reached); for context, the CARTITUDE-4 standard-of-care arm (PVd or DPd) reported median PFS 11.8 months (HR 0.29 favoring cilta-cel in the overall trial). Safety remained CAR-T-typical and infection-heavy: CRS occurred in 73.4% (high-risk) vs 70.0% (standard-risk), ICANS 7.8% vs 0%, grade 3/4 infections 43.8% vs 30.0%, and NRM occurred in 7 vs 2 patients (including 4 infection-related deaths in the high-risk group); notably, no IEC-parkinsonism cases were observed in either subgroup.