Phase III CARTITUDE-4 study of Carvykti meets primary endpoint in multiple myeloma.- Legend Biotech Corp
Legend Biotech Corp announced that CARTITUDE-4, the Phase III 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 III 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. Results from the CARTITUDE-4 study will be submitted to an upcoming medical meeting and will support discussions with health authorities about potential regulatory submissions.
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