AstraZeneca's combination of Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy has been approved by the European Union for the treatment of advanced lung and liver cancers. The approvals permit the use of Imfinzi with Imjudo for the treatment of adult patients suffering from unresectable and advanced hepatocellular carcinoma (HCC) and in combination with Imjudo and platinum-based chemotherapy for the treatment of metastatic (Stage IV) non-small cell lung cancer (NSCLC) in adults.
The European Commission approved the two immunotherapies based on positive recommendations from the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022. The approval is based on results from HIMALAYA Phase III trial and the POSEIDON Phase III trial published in the New England Journal of Medicine Evidence and the Journal of Clinical Oncology, respectively. The approval for HCC treatment is based on the HIMALAYA trial, which showed a significant reduction in death risk by 22% compared to sorafenib. The approval for the treatment of metastatic NSCLC is based on results from the POSEIDON trial, which showed a significant reduction in the risk of death by 23%.
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