China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has submitted a Type II variation application to the European Medicines Agency (EMA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The application is supported by data from the CARTITUDE-4 study, a randomized Phase III trial that evaluated the efficacy and safety of cilta-cel in comparison to standard treatments for patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy.
CARTITUDE-4 Study Results and Implications
The topline data from the CARTITUDE-4 study indicated a significant 74% reduction in the risk of disease progression for patients treated with cilta-cel compared to standard treatment, as reported in previous leaks. These results have positioned Carvykti as a potential new option for patients with multiple myeloma in the European market.
Global Partnership and Approval Status
Legend Biotech is developing Carvykti in a global partnership with Johnson & Johnson’s (J&J) subsidiary, Janssen Biotech. The drug received its first approval in the United States in March 2022 as a fourth-line multiple myeloma (MM) treatment. In December 2022, the National Medical Products Administration (NMPA) accepted the market approval filing for review in China. Carvykti is currently the subject of multiple ongoing studies aimed at expanding its indications to earlier stages of treatment, including first-line use.
Commercial Performance of Carvykti
Carvykti has demonstrated strong commercial performance, generating USD 55 million in sales during Q4 2022. The drug’s potential approval in Europe would further expand its market reach and could provide additional treatment options for patients with multiple myeloma across the globe.-Fineline Info & Tech
