AstraZeneca’s Imfinzi Recommended For EU Approval In NSCLC Treatment

AstraZeneca’s Imfinzi (durvalumab), combined with chemotherapy, has been recommended for approval in the European Union (EU) to treat adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The treatment is intended for patients without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, Imfinzi is administered with neoadjuvant chemotherapy before surgery and as an adjuvant monotherapy post-surgery. 

Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and investigator in the trial, said in a statement, “Adding perioperative durvalumab to neoadjuvant chemotherapy significantly improved outcomes for patients with resectable non-small cell lung cancer, who experience high rates of recurrence and poor outcomes. Today’s recommendation marks an important step towards patients and their clinicians in Europe gaining access to an innovative treatment that should become a backbone combination approach in this curative-intent setting.”

The recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is based on results from the pivotal AEGEAN trial, published in The New England Journal of Medicine. Interim data showed that the Imfinzi-based perioperative regimen reduced the risk of recurrence, disease progression, or death by 32% compared to neoadjuvant chemotherapy alone. 

Additionally, the pathologic complete response (pCR) rate was significantly higher at 17.2% versus 4.3% for chemotherapy alone. Overall survival (OS) data presented at the 2024 World Conference on Lung Cancer indicated a favorable trend for the Imfinzi-based approach, though statistical significance was not tested at this stage.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, also mentioned, “This recommendation highlights the potential of Imfinzi to address an unmet need for patients with resectable lung cancer who need new treatment options that increase the time they live without recurrence or progression. AEGEAN underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.”

Lung cancer remains a major health challenge in Europe, with over 450,000 new cases diagnosed annually. While 25-30% of NSCLC patients are diagnosed early enough for surgery, recurrence is common, and survival rates decline with disease progression. Imfinzi demonstrated a well-tolerated safety profile in both neoadjuvant and adjuvant settings, with no new safety concerns. Already approved in the US and several other countries based on AEGEAN trial results, Imfinzi is also under regulatory review in China, Japan, and additional markets.