China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has filed a 6-K with the US Securities and Exchange Commission and published clinical studies with the European Hematology Association (EHA) regarding its chimeric antigen receptor (CAR)-T therapies. The release confirms the strength of Carvykti in earlier treatment stages for multiple myeloma (MM), as reported by Fineline Info & Tech.
Phase III CARTITUDE-4 Study Results
The first Phase III results of the CARTITUDE-4 study compared Carvykti (ciltacabtagene autoleucel) with the standard of care (SOC) in recurrent and lenalidomide refractory multiple myeloma. The conclusion was that a single cilta-cel infusion significantly improves the progression-free survival (PFS) of refractory lenalidomide patients who have previously received line 1-3 treatment, with a good benefit/risk ratio. The 74% reduction in progression/death risk, along with a high proportion of complete remission (CR) and extremely low minimal residual disease (MRD) negative rates, highlight cilta-cel’s potential as a key treatment for patients with multiple myeloma after a single recurrence.
CARTITUDE-1 Final Results
The final results of the Ib/II Study for Carvykti in recurrent or refractory multiple myeloma after multiple treatments showed that RR/MM patients who have undergone multi-line treatment observed a median PFS longer than previously reported treatment methods after receiving a single infusion of cilta-cel. Reaching CR and/or sustained negative MRD is associated with prolonged PFS. Patients will continue to be followed up on safety and survival in the 15-year CARTITUDE-CONTINUE long-term study (NCT05201781; MMY4002).
LEGEND-2 Study: Long-term Remission and Survival
The LEGEND-2 study with a follow-up of at least five years showed that RR/MM patients who received multi-line treatment with LCAR-B38M CAR-T had a median overall survival of 55.8 months, and 18% of patients were asymptomatic. Five years of follow-up data indicate that patients who have undergone less frontline treatment or are in good functional condition may benefit more from LCAR-B38M CAR-T cell therapy and may be cured.-Fineline Info & Tech
