The China NMPA accepts sNDA for Junshi Biosciences Toripalimab as the 1L treatment for ES-SCLC

CAR-T Digest - August 2020

19 Jul 2023: Toripalimab / 1L ES-SCLC / Junshi Biosciences: The China NMPA accepted the sNDA for review

Junshi Biosciences seeks NMPA approval for Toripalimab in combination with platinum-based chemo and Etoposide as a 1L treatment option for patients with ES-SCLC
This sNDA was mainly based on the positive results from EXTENTORCH trial
In May 2023, the primary endpoints of the EXTENTORCH study met the pre-defined efficacy boundary, and Toripalimab thus became the first PD-1 inhibitor in the world which had met the primary endpoints of both overall survival
- Toripalimab in combination with chemo for the first-line treatment of ES-SCLC demonstrated significantly prolong patients’ PFS and OS when compared to chemo alone
- The safety profile of Toripalimab was similar to previous studies, and no new safety signals were identified
Detailed data will be presented at an upcoming international academic conference