Phase 3 CAR-T Cell Therapy Trial Achieves Significant Survival Improvement in Multiple Myeloma

Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy. The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI versus standard therapies. Safety data were consistent with the approved label.

CARTITUDE-4 (NCT04181827) is the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI. The study compares CARVYKTI with standard of care treatments PVd or DPd in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The primary endpoint of the study is progression-free survival (PFS); safety, OS, minimal residual disease negative rate and overall response rate are secondary endpoints.

"CARVYKTI, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line," said Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. "As we continue to strive to change outcomes and advance care for every person living with multiple myeloma, we're excited to share these results, which add to the growing body of evidence across our portfolio of differentiated, complementary therapies that attack the disease in different ways throughout the course of a patient's journey."

Updated results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.