Phase 3 Trial Results for Loqtorzi Show Positive Results in Advanced Hepatocellular Carcinoma Patients

Phase 3 trial results for Loqtorzi (toripalimab) and Avastin (bevacizumab) show that in first-line patients suffering from advanced hepatocellular carcinoma (HCC), the combination therapy containing the PD-1 inhibitor has exponentially increased overall survival (OS) and progression-free survival (PFS).

The trial achieved both its primary goals, and after becoming the first PD-1 inhibitor made in China to gain FDA approval 8 months ago, Loqtorzi is now on its way to gaining clearance for a second indication.

Junshi and Coherus’ Loqtorzi won its initial approval for head and neck cancer, and these new trial results are helping it move towards liver cancer approval.

The trial, dubbed HEPATORCH, also reached its secondary endpoints, including those related to time to progression and objective response rate measures. The study was conducted by comparing the combination therapy with Bayer’s Nexavar, currently the standard treatment for the disease, and showed no new safety signals according to a company release by Junshi.

Jia Fan, the principal investigator of the HEPATORCH study, explained, “Currently, the combination of immune checkpoint inhibitors and anti-angiogenesis targeted therapies has become a vital first-line treatment for advanced liver cancer. As the first innovative biological drug independently developed and produced in China to receive FDA approval, toripalimab has received international recognition for its quality.”

The details of the study data are yet to be revealed and will be unveiled at an international conference in the near future. When it comes to gaining approval for Loqtorzi in HCC, Junshi said it plans to submit an FDA application soon.

Marketed as Tuoyi, Loqtorzi gained approval as a monoclonal antibody in China in 2018. However, in the U.S., it first had to go through two complete response letters from the FDA before being approved in October 2023 for a type of head and neck cancer called nasopharyngeal carcinoma (NPC) in its recurrent or metastatic form.

Additionally, the monotherapy can only be administered to patients who previously received chemotherapy or in combination with chemotherapy for first-line patients.

Junshi’s treatment was officially launched in the U.S. in early January by its commercial partner Coherus, and in the first quarter alone, it brought in around $2 million in sales. According to NIH estimates, more than 14,000 deaths occurred from NPC in the U.S. between 2000 and 2020, and for HCC, the number goes as high as 330,000. By venturing into this field, Junshi and Coherus will further expand their market.

In 2022 alone, there were 866,000 new cases and 759,000 deaths reported worldwide from liver cancer, with HCC accounting for 90% of liver cancer cases. The median overall survival for HCC is around 10 months, and the 5-year survival rate is only 12%. According to Junshi, treating patients suffering from this disease with immunotherapy combinations can increase their chances of survival.

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