Junshi's Tuoyi Achieves Survival Goals in Liver Cancer Study

Junshi Biosciences recently announced promising results from a Phase III study of their anti-PD-1 antibody, Tuoyi (toripalimab), combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC). The study met its primary endpoints, showing significant improvements in both progression-free survival (PFS) and overall survival (OS). These results have encouraged the company to plan for imminent regulatory submissions to market this combination therapy for HCC.

Jianjun Zou, the chief executive of Junshi, emphasized the significance of these findings, suggesting that Tuoyi may become a key component of immuno-oncology for HCC in China. This comes at a crucial time, as HCC continues to show high incidence and mortality rates in the country. The study, named HEPATORCH, compared the efficacy of the Tuoyi and bevacizumab combination against Bayer’s Nexavar (sorafenib), a standard treatment for unresectable or metastatic HCC. Findings revealed that the Tuoyi/bevacizumab duo not only extended PFS and OS more effectively than Nexavar but also showed better secondary outcomes, such as higher objective response rates and longer time to progression. Importantly, the safety profile of the combination was in line with previous studies, with no new safety concerns emerging. These detailed results are scheduled to be shared at an upcoming medical conference.

Jia Fan, the principal investigator, highlighted the potential of this treatment, noting that the combination of immune checkpoint inhibitors with anti-angiogenesis targeted therapies is becoming a crucial first-line option for advanced liver cancer. He praised Tuoyi as a new treatment avenue offering better survival benefits for patients.

Currently, Tuoyi is approved in China for a variety of solid tumors, such as melanoma, nasopharyngeal carcinoma (NPC), urothelial carcinoma, oesophageal squamous cell carcinoma (ESCC), renal cell carcinoma, and non-small-cell lung cancer. Earlier this year, the PD-1 inhibitor received approval in the United States for the treatment of recurrent or metastatic NPC, where it is marketed by Coherus Biosciences under the name Loqtorzi. Additionally, the drug is pending approval in the European Union for advanced NPC and ESCC.

The study's outcomes offer hope for improved first-line treatment options for advanced HCC, especially in regions with high disease burden. Junshi's Tuoyi is set to play a significant role in reshaping the therapeutic landscape for liver cancer, potentially providing patients with more effective and safer treatment alternatives.