Johnson & Johnson: CARVYKTI single infusion achieved five-year treatment-free remissions in 50% of early-line RRMM patients

Study design

Phase 2 CARTITUDE-2 cohort A enrolled 20 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor and were refractory to lenalidomide. The primary endpoint was minimal residual disease (MRD) negativity. Patients received a single infusion of ciltacabtagene autoleucel (CARVYKTI) and were followed for long-term outcomes without maintenance therapy.

Five‑year efficacy

At a median follow-up of 60.7 months, 10 of 20 patients (50%) remained alive and progression-free at five years without maintenance. Median progression-free survival was 60.5 months and the five‑year overall survival rate was 69.2%. MRD by bone marrow was assessed at five years in three patients; all three were MRD‑negative at 10⁻⁶. Durable remissions included patients with high‑risk cytogenetic features: among the 10 progression‑free patients at five years, five had at least one high‑risk abnormality and four had two or more.

Safety and follow-up events

The longer follow-up reported no new CAR T‑cell‑related neurotoxicity beyond the known profile. Since the prior analysis one patient developed acute myeloid leukemia and two further deaths occurred (progressive disease and new cancer). The dataset was presented at the 2026 International Myeloma Society Annual Meeting and contributes to ongoing evaluation of earlier use of CARVYKTI in multiple myeloma.