Raritan, N.J. – September 25, 2026 -- Half of patients with early-line relapsed or refractory multiple myeloma treated with a single infusion of Johnson & Johnson's CARVYKTI® (ciltacabtagene autoleucel) remained alive and progression-free for at least five years without maintenance therapy, according to new long-term data from the Phase 2 CARTITUDE-2 study.
Half of patients reach five-year progression-free survival without maintenance
In the initial subgroup of cohort A (N=20), 10 of 20 patients treated with a single CARVYKTI® infusion remained progression-free at a median follow-up of 60.7 months. Median progression-free survival reached 60.5 months, and the results were presented at the International Myeloma Society Annual Meeting (Abstract #PA-288). Cohort A enrolled patients who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.
Five-year overall survival reaches 69.2%, MRD negativity confirmed
The five-year overall survival rate was 69.2%. Of three patients assessed for minimal residual disease at the five-year mark via bone marrow testing, all three were MRD-negative at the deepest sensitivity threshold tested (10-6), indicating no detectable disease.
High-risk patients also achieve durable remission without maintenance
Of the 10 patients who remained alive and progression-free at five years, five carried at least one high-risk cytogenetic abnormality, and four of those had two or more high-risk features. Niels van de Donk, M.D., Ph.D., Professor of Hematology at University Medical Center Amsterdam, said treatment-free remissions of this duration were difficult to imagine five years ago for relapsed or refractory multiple myeloma patients, and that the findings support using highly effective therapies earlier in the disease course to enable deeper, more durable disease control without maintenance.
Safety profile remains consistent, with two new malignancy-related deaths reported
The safety profile with longer follow-up matched the known profile of CARVYKTI®, with no new CAR T-cell-related neurotoxicity reported. Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia), and two deaths occurred due to progressive disease and a new cancer. CARVYKTI® is available in 17 markets and has treated more than 13,000 patients globally to date.