Legend Biotech Announces Phase 3 CARTITUDE-4 Study of CARVYKTI® (ciltacabtagene autoleucel) Has Met Its Primary Endpoint in the Treatment of Patients with Relapsed and Refractory Multiple Myeloma


SOMERSET, N.J.– Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis. The study has been unblinded following the recommendation of an independent data monitoring committee.

The CARTITUDE-4 (NCT04181827) study is the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of a CAR-T therapy versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (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 PFS. Secondary endpoints include safety, overall survival (OS), minimal residual disease (MRD) negative rate and overall response rate (ORR). Patients will continue to be followed for primary and secondary endpoints as part of the CARTITUDE-4 study.

“Autologous CAR-T cell therapy represents a major breakthrough in cancer treatment, and topline results from CARTITUDE-4 support our continuous efforts to bring this treatment option to patients with multiple myeloma in various stages of disease progression,” Lida Pacaud, M.D., Vice President of Clinical Development and Medical Affairs at Legend Biotech, said.