Imjudo/Imfinzi Approved for Liver Cancer

FDA has approved AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable hepatocellular carcinoma, the most common type of liver cancer.

Approval was based on data from the HIMALAYA Phase 3 trial, which showed that patients treated with the combination saw a 22% reduction in the risk of death versus chemotherapy sorafenib (Bayer’s Nexavar), AstraZeneca says. “Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up,” it says.

The company also says the safety profile of the combination was consistent with the known profiles of each medicine, and no new safety signals were observed.