Toripalimab + chemotherapy for treatment of advanced triple-negative breast cancer met its primary endpoint in phase III TORCHLIGHT study
The board of directors of the Shanghai Junishi Biosciences is pleased to announce that recently, a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“TORCHLIGHT Study”, NCT04085276) of the Company’s product toripalimab (trade name: Tuoyi, product code: JS001) in combination with paclitaxel for injection (albumin-bound) in patients with initial diagnosis of stage IV or recurrent metastatic triple-negative breast cancer has finished the pre-specified interim analysis
The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint has met the pre-defined efficacy boundary. The Company will communicate with the regulatory authorities regarding matters related to the supplemental new drug application in the near future.
The TORCHLIGHT study is the first Phase III registration study in China to achieve a positive outcome in an advanced triple-negative breast cancer immunotherapy. This randomized, double-blind, placebo-controlled, multi-center Phase III clinical study was designed to compare the safety and efficacy of toripalimab combined with paclitaxel for injection (albumin-bound) and placebo combined with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV breast cancer or recurrent/metastatic triple-negative breast cancer.
The interim analysis of this study demonstrated that, compared with paclitaxel for injection (albumin-bound), toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with initial diagnosis of stage IV or recurrent metastatic triple-negative breast cancer can significantly prolong the progression-free survival (PFS) of PD-L1 positive patients. Meanwhile, the overall survival (OS), one of the secondary endpoints, also showed a clear trend of improvement in PD-1 positive patients as well as in all patients regardless of PD-1 status. The safety data of toripalimab is consistent with known risks, and no new safety signals were identified.
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