FDA Approves AstraZeneca’s Imjudo and Imfinzi Combo for Unresectable HCC

AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC).

Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T-cell activation and cancer cell death.

The approval was based on results from a phase 3 study in which the drug combination led to a 22 percent reduction in the risk of death compared to sorafenib.

The treatment regimen includes 300mg Imjudo as a single dose added to 1500mg Imfinzi followed by Imfinzi every four weeks.