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® (cilta-cel) for patients with relapsed or refractory multiple myeloma (RRMM). In 80% of patients with standard-risk cytogenetics who received CARVYKTI® as early as first relapse, the disease did not progress, and no further treatment was required at 2.5 years (30 months). 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 presented at the 2025 American Society of Hematology (ASH) Annual Meeting. Dr. Luciano J. Costa, M.D., Ph.D., emphasized that a single infusion of CARVYKTI for standard-risk patients may provide additional benefits as early as the second line of therapy, offering the opportunity for deeper and more durable responses, potentially leading to long-term remission and cure. Johnson & Johnson aims to treat patients as early as possible, when they have the best chance for lasting remission, with CARVYKTI having demonstrated robust efficacy as soon as first relapse and being the first and only CAR-T to significantly extend overall survival compared to standard therapies. The analysis of CARTITUDE-4 data showed 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 appeared to plateau at 80.5%, with all 26 patients who achieved 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 prior lines. These biomarker data identify potential immunologic factors associated with longer PFS and support the improved survival outcomes with CARVYKTI® for patients treated as early as second line. As CARVYKTI® use expands, 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 its use in earlier treatment settings.
