Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along with subgroup analysis results from the CARTITUDE-4 study.
The findings indicated that patients who had less than a complete response (CR) after front-line autologous stem cell transplant (ASCT) achieved profound and enduring responses following a single infusion of Carvykti, with or without lenalidomide maintenance. With a median follow-up of 22 months, patients treated with Carvykti (n=17) showed an overall response rate (ORR) of 94%, with all 16 patients achieving a CR or better. Among the 15 minimal residual disease (MRD)-evaluable patients, 80% reached MRD negativity at the 10–5 threshold. The median duration of response (mDOR) was not reached, and the median time to first response was one month. Both 18-month progression-free survival (PFS) and overall survival (OS) rates were 94% each.
The CARTITUDE-4 study, a Phase III trial, is assessing Carvykti against two standard of care therapies, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, dexamethasone (DPd), in patients with relapsed and lenalidomide-refractory multiple myeloma. This subgroup analysis revealed that Carvykti significantly improved PFS for patients with functionally high-risk (FHR) multiple myeloma, demonstrating higher ORR, ≥CR rates, MRD negativity rates, and improved PFS compared to standard of care.
Carvykti is being commercialized globally by Janssen Biotech, a subsidiary of Johnson & Johnson, in the US, Europe, and other markets. The therapy received its first major market approvals in 2023, starting with the US in March, followed by the European Medicines Agency (EMA) in May, and Japan, for heavily pre-treated patients with relapsed/refractory MM. The drug is currently awaiting its first regulatory decision in China.- Flcube.com
