Johnson & Johnson announced updated results from the Phase 3 CARTITUDE-4 study, supporting durable treatment-free remissions as early as second-line treatment with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or refractory multiple myeloma (RRMM). The study showed that in 80% of as-treated patients with RRMM and standard-risk cytogenetics, the disease did not progress and no further treatment was required at 2.5 years (30 months) after a single infusion as early as first relapse. These results add to the clinical and real-world experience established across more than 9,000 patients treated with CARVYKTI® globally. Additional analyses demonstrated improved immune fitness in earlier lines, suggesting a correlation with longer progression-free survival (PFS). The data were featured in oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting. Dr. Luciano J. Costa, M.D., Ph.D., emphasized the potential of a single infusion of CARVYKTI for standard-risk patients as early as second-line therapy, offering deeper and more durable responses, and shifting the treatment paradigm towards long-term remission and potentially cure. Johnson & Johnson aims to treat patients as early as possible, leveraging CARVYKTI's robust efficacy demonstrated in over 9,000 patients globally, and its ability to significantly extend overall survival compared to standard therapies. The analysis of CARTITUDE-4 data revealed that 176 patients received CARVYKTI as early as second-line, with 59 having standard-risk cytogenetics. At a median follow-up of 33.6 months, the 30-month PFS rate among standard-risk patients in the as-treated population plateaued at 80.5%, with all 26 patients achieving minimal residual disease (MRD)-negative complete response at 12 months remaining progression-free at 30 months. Translational analyses evaluated the relationship between immune biomarkers and PFS in patients treated with CARVYKTI in CARTITUDE-1 and CARTITUDE-4, showing stronger immune fitness in patients treated after one or two prior lines of therapy compared to those with three or more. These biomarker data identify potential immunological factors associated with longer PFS and support the improved survival outcomes exhibited with CARVYKTI for patients treated as early as second-line. As CARVYKTI's use expands across academic centers and community practices, Johnson & Johnson continues to collect and analyze clinical and real-world data to further characterize long-term remission outcomes and safety trends, providing a foundation for expanding use into earlier treatment settings.
