Phase III success for Junshi's toripalimab

22 February 2023

Shanghai Junshi Biosciences (HKEX: 1877) has announced positive results from a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TORCHLIGHT Study, NCT04085276) examining the company’s product toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV or recurrent/metastatic triple-negative breast cancer.

The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint met the pre-defined efficacy boundary. Junshi Biosciences will communicate with the regulatory authorities regarding matters related to the supplemental new drug application in the near future.

According to GLOBOCAN 2020, breast cancer had the highest incidence rates worldwide, with 2.26 million new cases and 0.68 million deaths in 2020. In China, 0.42 million new cases and 0.12 million deaths due to breast cancer were reported in 2020, accounting for 18.4% and 17.1% of global cases, respectively. Amongst these breast cancer cases, triple-negative breast cancer (TNBC) accounted for around 15% to 20% of them.

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