Thursday, July 18, 2024
reading time: 2 minutes
Shanghai Junshi Bioscience Co., Ltd. (Junshi Bioscience, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) review for toripalimab (trade name: TUOYI®, product code: JS001) in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Liver cancer, especially hepatocellular carcinoma (HCC), is a major malignant tumor of the gastrointestinal tract worldwide, accounting for about 90% of cases. The 2022 GLOBOCAN report documented 866,000 new cases of liver cancer and 759,000 deaths worldwide, with China bearing a large burden of the disease. In 2022, China reported 368,000 new cases of liver cancer, accounting for 42.4% of the global incidence, and 317,000 deaths, accounting for 41.7% of global liver cancer deaths. Liver cancer ranks fourth in new cases and second in deaths among local malignancies in China. Due to its asymptomatic nature, 70%-80% of HCC patients in China are diagnosed in the intermediate or advanced stages, with a median overall survival (OS) of about 10 months and a 5-year survival rate of about 12%. Recent developments in combination therapies that include immunotherapy drugs have revolutionized the treatment of advanced liver cancer, making radical cure more achievable.
The NDA submission is based on the HEPATORCH study (NCT04723004), a multicenter, randomized, open-label, active-controlled, phase III clinical trial designed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the treatment of unresectable or metastatic HCC, compared with standard sorafenib. Led by principal investigator Professor Jia Fan, president of Zhongshan Hospital of Fudan University and academician of the Chinese Academy of Sciences, the HEPATORCH study was conducted at 57 centers in China.
In June 2024, the HEPATORCH study’s primary endpoints of progression-free survival (PFS, based on independent radiological review) and overall survival (OS) met prespecified efficacy criteria. The study showed that toripalimab in combination with bevacizumab significantly improved PFS and OS in patients with advanced HCC compared with sorafenib, while also improving secondary endpoints such as objective response rate and time to progression. The safety profile of toripalimab was consistent with known risks, and no new safety concerns were identified. Detailed results will be presented at an upcoming international academic conference.
