AstraZeneca recently announced that the China National Medical Products Administration (NMPA) has officially approved durvalumab (trade name: Imfinzi® ) in combination with tramapimab (trade name: Imfinzi® ) for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In addition, durvalumab has also been approved as monotherapy for first-line treatment of adult patients with advanced or unresectable HCC.

According to the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition)," the number of new cases of primary liver cancer in China in 2022 was 367,700, accounting for 42.5% of global cases; the number of deaths from primary liver cancer in 2022 was 316,500, ranking second in both the number of deaths and the case fatality rate; the 5-year relative survival rate of liver cancer in the Chinese population was 14.4%, and the proportion of patients diagnosed at intermediate or advanced stages reached more than 50%.

This approval for a new indication is based on positive results from the global Phase III HIMALAYA study and the Chinese cohort. The HIMALAYA study is the world's first Phase III trial of a dual immunotherapy combination therapy for unresectable HCC.

https://mp.weixin.qq.com/s/-K9Cdpicdk2NSDYOmGWhyg