Shanghai’s Junshi Biosciences Co. (The Company) recently announced in Biospace, that its product, toripalimab (TUOYI®), combined with bevacizumab as a first-line therapy for hepatocellular carcinoma (HCC), met its endpoints in a recent study. Results of the Phase III CHEPATORCH study (NCT04723004) included progression-free survival and overall survival.
The company intends to present an application (NDA) to the regulatory authorities shortly.
Malignant liver tumors in the digestive system are common. HCC accounts for approximately 90% worldwide. Biospace reported 866,000 new cases of HCC and 759,000 deaths globally in 2022.
China reports having a disproportionate number of liver cancer cases. In 2022 new cases totaled 368,000 (42.4% of cases worldwide) while the number of deaths totaled 317,000.
About 70-80% of China’s patients reporting liver cancer are generally approaching the moderate to advanced stage when the malignancy is discovered.
Overall survival is generally ten months after diagnosis.
However, there has recently been an emergence of combination therapies that have changed the treatment landscape making a radical cure a possibility. When PD1 and PD2 are blocked, the immune system’s ability to kill tumor cells increases.
About the Study
The HEPATORCH study is an open-label, controlled Phase III clinical study that aims to assess the safety and efficacy of toripalimab combined with bevacizumab for metastatic or unresectable HCC comparing the combination to standard sorafenib treatment.
The study analyzed the combination for patients who are in the advanced stages of HCC. There appears to be growing evidence that the combination could prolong progression free survival and overall survival.
Secondary endpoints also improved such as the time leading to progression and the response rate.
About Safety
Toripalimab remained consistent. There were no new safety risks. Additional details are expected to be presented at a future international conference.
Professor Jia FAN, principal investigator at the Zhongshan, Hospital commented that combining anti-angiogenesis targeted therapies and immune checkpoint inhibitors is now a first-line approach for liver cancer in advanced stages. The professor added that toripalimab has received marketing approval in the United States and has been recognized internationally for its effectiveness. It is the first novel biological drug produced and developed in China that has received FDA approval.
To date, over 40 company-sponsored clinical studies involving toripalimab were conducted by Junshi worldwide. This includes both ongoing or completed clinical trials assessing the efficacy and safety of toripalimab and covering a wide range of tumor types. In China, toripalimab is approved as TUOYI®. There are eight approved indications for toripalimab (details are available here).
About the Company
Junshi Biosciences Co. Ltd (Junshi) is a leading innovation-driven biopharmaceutical company, dedicated to the discovery, development, and commercialization of novel therapies. Junshi plans to submit a supplemental new drug application (“NDA”) for toripalimab to the U.S. regulatory authorities in the near future.
