Johnson & Johnson today announced compelling long-term data from the Phase 3 CARTITUDE-4 study, providing strong evidence that earlier use of the CAR T-cell therapy CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) leads to durable, treatment-free remissions in patients with relapsed or refractory multiple myeloma (RRMM).
The updated results, presented at the 2025 American Society of Hematology (ASH) Annual Meeting, showed that at 2.5 years (30 months) following a single infusion of CARVYKTI:
- 80 percent of as-treated patients with standard-risk cytogenetics who received CARVYKTI as early as first relapse remained progression-free and treatment-free.
- 100 percent of the standard-risk patients in this group who achieved a minimal residual disease (MRD)-negative complete response at 12 months were still progression-free at 30 months.
CARVYKTI is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy. It is the first and only CAR T-cell therapy to demonstrate a significant extension in overall survival compared to standard-of-care therapies in this earlier setting.
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The CARTITUDE-4 study is the first randomized Phase 3 trial to evaluate CARVYKTI against standard of care (pomalidomide/bortezomib/dexamethasone [PVd] or daratumumab/pomalidomide/dexamethasone [DPd]) in adult patients with lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy.
Immune Fitness Linked to Longer Survival
Additional translational analyses supported the strategy of earlier intervention. The data showed that patients who received CARVYKTI after one or two prior lines of therapy demonstrated improved immune fitness compared to those with three or more prior lines. This was characterized by increased baseline CD4⁺ naïve T cells, suggesting that the patient’s immune system is better equipped to respond to the therapy in earlier lines, potentially correlating with longer progression-free survival (PFS).
These data suggest that a single infusion of CARVYKTI for standard-risk patients may provide additional benefit to patients as early as second line of therapy. Treating patients after first relapse offers the opportunity to achieve deeper and more durable responses, shifting the treatment paradigm closer to the possibility of long-term remission and, ultimately, cure.
Dr. Luciano J. Costa
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