Junshi, Coherus' PD-1 inhibitor Loqtorzi succeeds in phase 3 liver cancer trial

In October, the FDA granted approval for Junshi and Coherus' drug Loqtorzi (toripalimab) for the treatment of head and neck cancer. Following this milestone, the drug appears poised to secure another approval, this time for liver cancer, based on promising results from a recent clinical trial.

Just eight months after becoming the first PD-1 inhibitor developed in China to receive U.S. approval, Loqtorzi has shown significant potential in treating advanced hepatocellular carcinoma (HCC). On Wednesday, Junshi announced that a phase 3 trial, named HEPATORCH, demonstrated notable success. The trial tested Loqtorzi in combination with Avastin (bevacizumab) against Bayer's Nexavar, the current standard treatment for HCC. The combination therapy not only met its primary goals but also outperformed Nexavar in prolonging both progression-free survival (PFS) and overall survival (OS) for patients receiving their first line of treatment for advanced HCC.

The results are encouraging, with Junshi revealing that secondary endpoints, including objective response rate and time to progression, were also achieved. Importantly, no new safety issues were identified. Junshi plans to submit applications for this new indication for Loqtorzi in the near future, potentially expanding its therapeutic reach in the U.S. market.

Loqtorzi, marketed as Tuoyi in China, received its initial approval there in 2018. However, the journey to U.S. approval was more challenging, involving two complete response letters from the FDA before finally being approved in October 2023. This approval was for treating recurrent or metastatic nasopharyngeal carcinoma (NPC), a type of head and neck cancer, either as a monotherapy for patients who had previously received chemotherapy or in combination with chemotherapy for first-line patients.

Since its U.S. launch by Coherus on January 2, Loqtorzi has generated $2 million in sales in its first quarter. The potential market for HCC treatment is significantly larger. The National Institutes of Health (NIH) reported nearly 330,000 deaths from HCC in the U.S. between 2000 and 2020, compared to over 14,000 deaths from NPC. HCC represents about 90% of all liver cancer cases, and in 2022 alone, there were 866,000 new cases and 759,000 deaths globally, with China accounting for 42% of these figures. Junshi highlighted the disease's "insidious onset," noting that 70% to 80% of liver cancer patients in China are diagnosed at an intermediate or advanced stage.

Despite HCC's grim statistics, with a median overall survival of 10 months and a five-year survival rate of just 12%, immunotherapy combinations are offering new hope. Jia Fan, the principal investigator of the HEPATORCH study, emphasized the growing importance of combining immune checkpoint inhibitors with anti-angiogenesis targeted therapies as a first-line treatment for advanced liver cancer. He praised toripalimab as the first innovative biological drug independently developed and produced in China to receive FDA approval, recognizing its international quality.

In summary, the successful results of the HEPATORCH study signal a significant step forward for Loqtorzi, both in terms of its potential new indication for liver cancer and its growing recognition as a high-quality, innovative treatment option within the global pharmaceutical landscape.