Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its randomized, double-blind, placebo-controlled, multi-center Phase III Neotorch study has completed the pre-set interim analysis. The study assessed the efficacy and safety of its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy as a perioperative treatment for patients with operable non-small cell lung cancer (NSCLC). The primary endpoint of event-free survival (EFS) was achieved with a significant level of superiority, prompting the Chinese firm to file for a new indication approval in China in the near term.
Interim Analysis Results
According to the interim analysis, toripalimab combined with chemotherapy significantly prolonged the EFS of patients with stage III operable NSCLC during perioperative treatment and subsequent consolidation therapy with toripalimab alone, compared to chemotherapy alone. The safety data were consistent with known risks, and no new safety signals were identified.
Toripalimab Development and Approvals
Toripalimab was the first domestic PD-1 inhibitor approved in China (in December 2018) as a second-line treatment for melanoma. Subsequent approvals were granted in February 2021 for nasopharyngeal carcinoma (NPC), in April 2021 for locally advanced or metastatic urothelial cancer (UC), in November 2021 for first-line NPC, and in May 2022 for first-line esophageal squamous cell carcinoma (ESCC). The drug was included on China’s National Reimbursement Drug List (NRDL) for three indications in 2020, making it the only PD-1 inhibitor for melanoma and NPC on the list. Over 30 clinical studies have been initiated globally, covering a range of cancers including lung, nasopharyngeal, esophageal, gastric, bladder, breast, liver, kidney, and skin cancers.
Global Regulatory Progress
Tuoyi is currently under Biologics License Application (BLA) review by the US FDA and has been filed in the EU and UK for the treatment of NPC and ESCC. This global regulatory progress underscores Junshi Biosciences’ commitment to expanding the therapeutic reach of toripalimab.-Fineline Info & Tech
