Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities have accepted for review another indication approval filing for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with paclitaxel (albumin bound) for the treatment of PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic triple negative breast cancer.
Filing Based on TORCHLIGHT Study Results
The filing is supported by the TORCHLIGHT study, a randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of the combination therapy in initially diagnosed stage IV or recurrent metastatic triple negative breast cancer. Conducted across 56 centers in China, the study successfully reached its primary endpoint in February 2023, demonstrating that toripalimab significantly prolonged progression-free survival. Additionally, the overall survival secondary endpoint showed clear benefits for both the entire population and the PD-L1 positive population. The safety data was consistent with known risks, with no new safety signals identified.
Tuoyi’s Track Record and Ongoing Filings
Tuoyi, China’s first domestic PD-1 inhibitor, was approved in December 2018 as a second-line treatment for melanoma. To date, it has received six indication approvals in China. Multiple market filings for the drug are currently under review in the US, EU, and UK. Junshi Biosciences filed the 7th indication for the drug in China early last month, for perioperative treatment combined with chemotherapy and as consolidation therapy alone after adjuvant therapy for resectable stage III non-small cell lung cancer (NSCLC).-Fineline Info & Tech
