FDA Advisory Committee reviewed Imfinzi (durvalumab) for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results – AstraZeneca

The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile.

In the trial, adult patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements were treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The discussion noted that while the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, this is an important potential regimen for patients.

The FDA accepted the supplemental Biologics License Application (sBLA) in September 2023 for Imfinzi in this indication based on positive results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine in October 2023.

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: “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, which can significantly increase the time patients live without progression and recurrence events in this curative-intent setting.”

See-

NEJM:. 389 NO. 18Nov 02, 2023 “Perioperative Durvalumab for Resectable Non–Small-Cell Lung Cancer”-J.V. Heymach and Others. N Engl J Med 2023;389:1672-1684.