FDA Advisers Call for Revamp of Perioperative Lung Cancer Trials Due to Frustration with AstraZeneca’s Imfinzi Design

1. FDA Advisory Committee Review: The FDA's Oncologic Drugs Advisory Committee (ODAC) reviewed AstraZeneca's Imfinzi (durvalumab) for the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results.
2. Imfinzi's Efficacy: Imfinzi met the primary endpoint of event-free survival (EFS) with a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death versus chemotherapy alone.
3. Safety Profile: Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings.
4. Regulatory Status: Imfinzi is approved in Switzerland and the UK for resectable NSCLC and is under review in the EU, China, and other countries.
5. ODAC Recommendations: FDA advisers expressed frustration with the trial design and called for a revamp of perioperative lung cancer trials.
6. Global Impact: Lung cancer is the leading cause of cancer death globally, with an estimated 2.4 million new diagnoses annually.