China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple myeloma patients.
Carvykti’s Impact on MRD Negativity Rates
The results indicated that a single infusion of Carvykti significantly increased MRD negativity rates (10-5) in patients with relapsed or refractory multiple myeloma (RRMM) who were lenalidomide refractory and had received one to three prior lines of therapy, including a proteasome inhibitor (PI). This improvement was compared to standard therapies of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).
Carvykti’s Global Commercialization and Partnership
Carvykti, a BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, is being commercialized in the US, Europe, and other global markets by partner Janssen Biotech, a subsidiary of Johnson & Johnson. The therapy received its first major market approvals in 2022, starting with the US in March, followed by the European Medicines Agency (EMA) in May, and Japan, all indicating its use for heavily pre-treated patients with relapsed/refractory multiple myeloma (MM).
Regulatory Approvals and Treatment Expansion
Carvykti was approved to treat second-line R/R MM in the US and European Union (EU) in April this year. China’s National Medical Products Administration (NMPA) granted approval for the drug to treat patients with R/R MM who had previously received at least third-line treatment, including the use of at least one proteasome inhibitor and immune modulator, in August this year.-Fineline Info & Tech
