AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine.

Each year in Europe, there are more than 450,000 people diagnosed with lung cancer. Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed at an early stage to have surgery with curative intent. However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years.4-5 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.

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: “Today’s approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable non-small cell lung cancer, who have historically faced high rates of recurrence and a poor prognosis. When added to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable non-small cell lung cancer, enabling more patients to access this important immunotherapy-based regimen. This new indication builds on the established role of Imfinzi in unresectable disease and underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.”

Imfinzi is approved in the US, China and several other countries in this setting based on the AEGEAN results. Regulatory applications are currently under review in Japan and additional countries in this indication.

Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease as not progressed after chemoradiotherapy (CRT) based on the PACIFIC Phase III trial.