The US has approved AstraZeneca‘s Imfinzi (durvalumab) combined with chemotherapy to treat adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) without known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients receive Imfinzi with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
The Food and Drug Administration (FDA) approved Imfinzi based on positive results from the pivotal AEGEAN trial, published in The New England Journal of Medicine in October 2023. Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902).
In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).
Each year, doctors diagnose an estimated 2.4 million people with lung cancer globally, including around 235,000 new cases expected in the US in 2024. They diagnose about 25-30% of all NSCLC patients, the most common form of lung cancer, early enough for 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.”
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The UK, Switzerland, and Taiwan (China) have also approved Imfinzi 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 serves as the global standard of care for treating unresectable Stage III NSCLC in patients whose disease does not progress after chemoradiotherapy, as demonstrated in the PACIFIC Phase III trial.
