Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival (PFS) and overall survival (OS). The company, based in China, is preparing to submit a new indication application for the programmed death-1 (PD-1) inhibitor to the regulatory authorities shortly.
Study results indicated that the combination therapy of toripalimab and bevacizumab significantly extended PFS and OS in patients with advanced HCC compared to sorafenib, which is the standard first-line treatment. Additionally, the combination improved the objective response rate and other secondary endpoints, such as time to disease progression. The safety profile of toripalimab aligns with known risks, and the study did not identify any new safety signals.
Toripalimab, the first domestically developed PD-1 inhibitor in China, received approval in December 2018 for second-line treatment of melanoma. It has since received a total of eight indication approvals within China and has six indications included in the National Reimbursement Drug List (NRDL).- Flcube.com
