China NMPA accepted sNDA for Junshi Bio’s Toripalimab and Chemo combo in TNBC

CAR-T Digest - August 2020

Weekly Digest - 20-26 May 2023

May 23, 2023: Toripalimab (IV) / Advanced Triple-Negative Breast Cancer / Junshi Bio: China NMPA accepted supplemental new drug application (sNDA)

This application was based on the findings from the Phase 3 TORCHLIGHT study
Data from the interim analysis showed that the addition of Toripelimab to chemo significantly improved progression-free survival
Toripalimab also showed a trend towards improved overall survival, regardless of PD-L1 status
Safety profiles were consistent with no new safety signals
Details of the TORCHLIGHT results will be published in the form of a “Late-breaking Abstract (LBA)” (#LBA1013) in ASCO 2023