AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combinations have been recommended for marketing authorisation in the European Union (EU) for advanced liver and lung cancers.

The concurrent positive opinions recommend authorising Imfinzi in combination with Imjudo for 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC); and Imfinzi in combination with Imjudo and platinum-based chemotherapy for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinions on results from the HIMALAYA Phase III trial, which was published in the New England Journal of Medicine Evidence, and results from the POSEIDON Phase III trial, which was published in the Journal of Clinical Oncology.

Bruno Sangro, MD, PhD, Director of the Liver Unit at Clínica Universidad de Navarra, Professor of Internal Medicine at the University of Navarra School of Medicine and a lead investigator in the HIMALAYA trial, said: “Liver cancer is a leading cause of cancer death in Europe, and patients with advanced disease face an especially grim prognosis with limited treatment options in the 1st-line setting. The combination of Imjudo and Imfinzi demonstrated a meaningful improvement in overall survival with no increase in severe liver toxicity or bleeding risk, which are important considerations for these patients who often have advanced disease.”

Solange Peters, MD, PhD, President of the European Society for Medical Oncology (ESMO), head of the medical oncology service and chair of thoracic oncology at Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and principal investigator in the POSEIDON trial, said: “Metastatic non-small cell lung cancer remains a complex and devastating diagnosis and there is still an urgent need for new life-extending treatment options. The latest data from the POSEIDON trial demonstrate the long-term survival benefit of Imjudo added to Imfinzi and chemotherapy and support the important role this novel combination could have for patients with metastatic non-small cell lung cancer in Europe.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Patients in Europe diagnosed with these advanced cancers urgently need treatment combinations that can help them live longer. If approved, these Imjudo and Imfinzi combinations will provide patients with novel options that harness the potential long-term survival benefits seen with CTLA-4 inhibition.”