Legend Biotech’s Phase 3 study of CARVYKTI shows ‘improved disease negativity’

The company states: “Legend Biotech (LEGN) announced new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI, ciltacabtagene autoleucel; cilta-cel, provided significantly higher rates of minimal residual disease (MRD)-negativity in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. MRD negativity is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma. These results reinforce the clinical value of CARVYKTI as early as second line and support the recent achievement of overall survival benefit versus standard therapies1. The MRD negativity findings were featured as an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California. The Phase 3 CARTITUDE-4 study evaluated CARVYKTI in comparison to standard therapies of PVd or DPd for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, including a PI and IMiD, and who were lenalidomide-refractory. In the trial, 208 adults were randomized to receive CARVYKTI, and 211 to receive standard therapies. The study assessed patients for MRD negativity at the 10-5 threshold. At a median follow-up of almost three years, evaluable patients treated with CARVYKTI achieved an MRD-negativity rate of 89% versus 38% for those treated with standard therapies. High rates of overall MRD-negativity were rapidly achieved with CARVYKTI with 69% of MRD-evaluable patients by day 56. At data cutoff, sustained MRD-negative greater than or equal toCR of at least 12 months was achieved in 52% of MRD-evaluable patients in the CARVYKTI arm vs. 10% in the standard of care arm . A post-hoc comparison of the CARTITUDE-4 and CARTITUDE-1 studies showed higher rates of MRD negativity, PFS, and OS were achieved when CARVYKTI was administered earlier in the treatment regimen. Data from CARTITUDE-4 supported the U.S. Food and Drug Administration and European Commission approval of CARVYKTI earlier this year for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI, and IMiD, and are refractory to lenalidomide.1 CARVYKTI is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI is now commercially available in five countries and has been utilized by over 4,500 patients.”