AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known 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 Food and Drug Administration (FDA) was based on positive results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine in October 2023.

Each year, there are an estimated 2.4 million people diagnosed with lung cancer globally, with approximately 235,000 new diagnoses expected in the US in 2024. Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed early enough 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. This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.

John V. Heymach, MD, PhD, Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center in Houston, Texas, said: “This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery. When added both before and after surgery, durvalumab delivered a significant and meaningful improvement in outcomes in this curative-intent setting.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment.”

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery versus chemotherapy alone.

Imfinzi is also approved in the UK, Switzerland and Taiwan (China) in this setting based on the AEGEAN results. Regulatory applications are also currently under review in the EU, China and several other countries in this indication.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.