Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study

Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) 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 indicated a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with Carvykti over standard therapies. Safety data were consistent with the approved label.

Carvykti is being commercialized in the US, Europe, and other global markets by its partner Janssen Biotech, a subsidiary of Johnson & Johnson. The therapy received its first major market approvals in 2022, with the US approval in March, followed by the European Medicines Agency (EMA) in May, and Japan, indicated for heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). It was approved in the US for second-line R/R MM in April this year. The drug is currently awaiting the first regulatory decision in China and generated USD 500 million and USD 159 million in sales for 2023 and the fourth quarter of 2023, respectively, according to a recent financial report.- Flcube.com

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