Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication for its PD-1 inhibitor Loqtorzi (toripalimab). The drug is now approved for use in combination with bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC), marking its eleventh approved indication in China.
Clinical Trial Results
The approval was based on results from the HEPATORCH study, a multi-center, randomized, open, positive-controlled Phase III trial conducted across 57 centers in China. The study compared the efficacy and safety of the toripalimab/bevacizumab regimen with the standard of care sorafenib in first-line HCC treatment. The Loqtorzi regimen demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sorafenib, with median PFS of 5.8 months versus 4.0 months and median OS of 20.0 months versus 14.5 months, respectively. The risk of disease progression or death was reduced by 31% (P=0.0086). The objective response rate (ORR) for the Loqtorzi regimen was significantly higher at 25.3% compared to 6.1% in the sorafenib group.
Safety Profile
The combination therapy showed a good safety profile, with a toxicity profile consistent with known monotherapy toxicity profiles and no new safety signals identified. This favorable safety profile supports the use of Loqtorzi in combination with bevacizumab as a first-line treatment option for patients with unresectable or metastatic HCC.-Fineline Info & Tech
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