IMFINZI (durvalumab) is approved in the US for the treatment of resectable non-small cell lung cancer before and after surgery

AstraZeneca’s IMFINZI (durvalumab) in combination with chemotherapy has been approved in the U.S. 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 Food and Drug Administration (FDA) approval was based on positive results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine in October 2023. Results from a planned interim analysis of event-free survival (EFS) demonstrated a statistically significant and clinically meaningful 32% reduction in the risk of relapse, 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).