Johnson & Johnson (NYSE: JNJ) reported five-year follow-up data from the Phase II CARTITUDE-2 study showing that half of patients with early-line relapsed or refractory multiple myeloma remained alive and progression-free after a single infusion of ciltacabtagene autoleucel (Carvykti), without maintenance therapy.
The analysis included 20 patients who had received one to three prior lines of therapy and were refractory to lenalidomide. At a median follow-up of 60.7 months, 10 patients remained alive and progression-free, median progression-free survival was 60.5 months, and the five-year overall survival rate was 69.2%.
The durability of response is notable because Carvykti is administered as a one-time autologous CAR-T treatment rather than continuous therapy. However, the dataset is small, and bone marrow MRD status was assessed in only three patients at five years; all three were negative at the deepest tested sensitivity of 10⁻⁶.
Long-term safety remained broadly consistent with the known Carvykti profile. Since the previous analysis, one patient developed acute myeloid leukemia and two deaths were reported, one from progressive disease and one from a new malignancy. Carvykti carries boxed warnings covering serious CAR-T toxicities, including secondary malignancies.