Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) as a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the first interim analysis stage. The study has been unblinded at the recommendation of the independent data monitoring committee.
CARTITUDE-4 Study Details
The CARTITUDE-4 (NCT04181827) study is the first international, randomized, open-label Phase III study comparing the efficacy and safety of the chimeric antigen receptor (CAR) T-cell therapy Carvykti to standard therapies, including pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd). The study enrolled adult patients with relapsed and lenalidomide-refractory MM who had received one to three prior lines of therapy.
Carvykti Development and Regulatory Milestones
Carvykti is being co-developed with US-based Janssen under a global licensing deal signed in December 2017. The drug was first approved by the US FDA in February 2022 for the treatment of relapsed and refractory MM in patients who had failed four or more lines of prior therapy. Approvals for this indication have also been granted in Europe and Japan. Carvykti is currently under review for approval in China, where it is the third BCMA CAR-T therapy to be filed, following those from IASO Bio/Innovent and CARsgen Therapeutics.-Fineline Info & Tech
