JW Therapeutics Receives the NMPA’s IND Clearance for the Clinical Trial of Carteyva (relmacabtagene autoleucel) as 2L Treatment of Large B-Cell Lymphoma
Shots:
- The P-III (JWCAR029-010) study to evaluate the efficacy & safety of Carteyva vs SoC in a ratio (1:1) adult patients with r/r LBCL, high-risk, relapsed in 12mos. or refractory from 1L treatment
- The 1EPs of the study are EFS as assessed by IRC & the 2EPs include CRR, PFS, OS, DoR, PK & safety. Additionally, the previous study showed that patients who could not achieve CR or maintain CR @≤1yr., ORR (29%), m-PFS (3mos.) & m-OS (10mos.)
- Carteyva is an autologous anti-CD19 CAR-T cell immunotherapy product & is being developed by JW. The therapy has been approved in China in Sept 2021 for the same indication & has been included in the national significant new drug development program, granted priority review & BTD
Ref: PR Newswire | Image: FinSME's
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