AstraZeneca PLC (LSE:AZN) announced that the US Food and Drug Administration (FDA) has approved the company's Imjudo (tremelimumab) drug in combination with Imfinzi (durvalumab) for treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The approval is based on results from the HIMALAYA Phase III trial, which showed that a single priming dose of the anti-CTLA-4 antibody Imjudo added to the anti-PD-L1 antibody Imfinzi reduced the risk of death by 22% compared with sorafenib, the pharmaceuticals company said.
Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. It is the fastest-rising cause of cancer-related deaths in the US, with approximately 36,000 new diagnoses each year, the FTSE 100-listed company said.
In a statement, Dave Fredrickson, executive vice president, oncology business unit at AstraZeneca, commented: "With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer."
Dr Ghassan Abou-Alfa, attending physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase III trial, said: "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease."
Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results, AstraZeneca said.