FDA Approval Insights: Perioperative Durvalumab for Resectable NSCLC

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by AstraZeneca, we had the pleasure of speaking with Sandip P. Patel, MD, and Brendon M. Stiles, MD, about the FDA approval of perioperative durvalumab (Imfinzi) for patients with resectable non–small cell lung cancer (NSCLC). Dr Patel is a professor of medicine in the Department of Medicine at the University of California, San Diego. Dr Stiles is a professor of cardiothoracic surgery and chief of the Divisions of Thoracic Surgery and Surgical Oncology in the Department of Cardiothoracic & Vascular Surgery, as well as the associate director of Surgical Oncology at the Montefiore Einstein Comprehensive Cancer Center in Bronx, New York.

On August 15, 2024, the FDA approved durvalumab plus platinum-containing chemotherapy in the neoadjuvant setting, followed by durvalumab monotherapy in the adjuvant setting, for the treatment of adult patients with resectable NSCLC with no known EGFR mutations or ALK rearrangements. This regulatory decision was backed by findings from the phase 3 AEGEAN trial (NCT03800134), in which the median event-free survival was not reached (95% CI, 31.9 months-not estimable [NE]) in patients who received the durvalumab regimen vs 25.9 months (95% CI, 18.9-NE) in those who received placebo plus chemotherapy (stratified HR, 0.68; 95% CI, 0.53-0.88; P = .0039).

In our exclusive interview, Drs Patel and Stiles discussed the significance of this approval, key efficacy and safety findings from AEGEAN, and how the clinical use of perioperative treatment regimens reinforces the importance of involving multidisciplinary teams in every step of a patient’s treatment plan.

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