Eight months after becoming the first China-made PD-1 inhibitor to score an approval in the United States, Junshi and Coherus’ Loqtorzi (toripalimab) appears set up to win clearance in a second indication.
On Wednesday, Junshi revealed that a phase 3 trial of Loqtorzi plus Avastin (bevacizumab) met its two primary goals, “significantly prolonging” the progression-free survival (PFS) and overall survival (OS) of first-line patients with advanced hepatocellular carcinoma (HCC).
In the HEPATORCH study, investigators compared the combo to standard therapy, which is Bayer's Nexavar. Junshi said that full data would be revealed at an upcoming international conference.
The company said the trial also hit its secondary endpoints, including on the measures of objective response rate and time to progression. Loqtorzi showed no new safety signals, the company said in a release.
Junshi said it plans to submit applications for approval of Loqtorzi in HCC in the “near future.”
In China, where it is marketed as Tuoyi, the monoclonal antibody was approved in 2018. But in the U.S., it was only endorsed after the FDA hit the companies with two complete response letters. The regulator finally signed off on Loqtorzi as a monotherapy for those who previously received chemo or in combination with chemo for first-line patients in October of 2023 to treat recurrent or metastatic nasopharyngeal carcinoma (NPC), a type of head and neck cancer.
Junshi’s commercial partner Coherus launched Loqtorzi in the U.S. on Jan. 2 and recorded $2 million in sales in the first quarter.
A larger patient population awaits in HCC. In the U.S. from 2000 to 2020, according to the NIH, there were nearly 330,000 deaths from HCC as opposed to more than 14,000 deaths from NPC.
HCC accounts for 90% of liver cancer cases. In 2022, there were 866,000 new cases and 759,000 deaths reported worldwide from liver cancer with 42% of the new cases and deaths occurring in China, Junshi said. Because of HCC’s “insidious onset,” according to Junshi, 70% to 80% of liver cancer patients in China are already in the intermediate or advanced stage upon first diagnosis.
While HCC carries a median overall survival of 10 months and a five-year survival rate of 12%, immunotherapy combinations are increasing the chances for survival, Junshi added.
“Currently, the combination of immune checkpoint inhibitors and anti-angiogenesis targeted therapies has become a vital first-line treatment for advanced liver cancer,” Jia Fan, the principal investigator of the HEPATORCH study, said in a release. “As the first innovative biological drug independently developed and produced in China to receive FDA approval, toripalimab has received international recognition for its quality.”