Coherus, Junshi's PD-1 Inhibitor Loqtorzi Succeeds in Phase III Liver Cancer Trial

Junshi Biosciences and Coherus BioSciences have released promising results from their Phase III clinical trial, HEPATORCH, which evaluates the effectiveness of the PD-1 inhibitor Loqtorzi (toripalimab) in combination with bevacizumab for treating advanced hepatocellular carcinoma (HCC). This combination significantly enhanced both progression-free and overall survival rates in patients when administered as a first-line treatment.

While specific data points were not disclosed in the announcement, the companies highlighted that the combination therapy also met several key secondary goals, such as improving the objective response rate and delaying the time to disease progression. Importantly, the safety profile of Loqtorzi was consistent with previous studies, and no new safety concerns were identified during the HEPATORCH trial.

The HEPATORCH study is a randomized, open-label, and active-controlled clinical trial comparing the efficacy of Loqtorzi plus bevacizumab against the current standard treatment, sorafenib, in patients with unresectable or metastatic HCC. Junshi and Coherus plan to present the complete findings and detailed analysis from the study at an upcoming international academic conference.

Jianjun Zou, CEO and General Manager of Junshi, emphasized the significance of these findings, describing Loqtorzi as a potential "cornerstone of immuno-oncology" due to its ability to significantly improve survival outcomes for patients with advanced HCC. He also expressed the company's commitment to working closely with regulatory authorities to expedite the approval process for the treatment, aiming to make it available to more patients suffering from advanced liver cancer.

Loqtorzi functions as a PD-1 receptor inhibitor, blocking the pathway that allows tumor cells to evade detection and attack by the immune system. This therapeutic monoclonal antibody received its first FDA approval in October 2023 for treating nasopharyngeal carcinoma, making it the first Chinese PD-1 inhibitor to enter the U.S. market.

In China, Loqtorzi is known as Touyi and was the first domestic PD-1 inhibitor approved for multiple indications, including unresectable or metastatic melanoma, recurrent or metastatic nasopharyngeal carcinoma, and locally advanced or metastatic urothelial carcinoma. It is currently approved for eight different indications.

The initial discovery and development of Loqtorzi were carried out by Junshi. In February 2021, Coherus acquired the rights to market Loqtorzi in the U.S. and Canada for $150 million upfront, with up to $380 million in additional milestone payments. This licensing agreement also granted Coherus the option to access several early-stage cancer drug candidates from Junshi.

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