Perioperative Durvalumab for Resectable Non-Small Cell Lung Cancer: Updated Outcomes From the Phase III AEGEAN Trial
In brief
Perioperative durvalumab reduces event-free risk by roughly 30% in resectable lung cancer
In the phase III AEGEAN trial, adding durvalumab to neoadjuvant chemotherapy cut the risk of an event (recurrence or death) by about one-third compared with chemotherapy alone, with median follow-up of 26 months. Disease-free survival also improved and overall survival trended higher, while grade 3-4 toxicities rose modestly to 15% versus 11%, supporting durvalumab as a new peri-operative option.
- Journal
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology (Q1)
- Published
- 28 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- John V Heymach, Jie He, David Harpole, Tetsuya Mitsudomi, Janis M Taube, Shugeng Gao, et al.
- PMID
- 42664473
- DOI
- 10.1200/JCO-25-02659
Why clinicians should know about it
- Picked for Breast and Endocrine Surgery (top studies of the week, 30 August 2026): High-quality evidence in a top journal
- Picked for Oncology and Radiation Oncology (top studies of the week, 30 August 2026): Perioperative durvalumab improves outcomes in resectable NSCLC (AEGEAN)
- Picked for Pathology and Forensic Medicine (top studies of the week, 30 August 2026): Phase III trial of perioperative durvalumab in NSCLC
- Picked for Surgery (top studies of the week, 30 August 2026): Perioperative durvalumab for lung cancer, oncology not general surgery focus
Abstract
In AEGEAN, perioperative durvalumab plus neoadjuvant chemotherapy, versus neoadjuvant chemotherapy alone, significantly improved event-free survival (EFS) and pathologic complete response in patients with resectable non-small cell lung cancer (R-NSCLC), with a safety profile consistent with the individual agents. We report EFS from a second planned interim analysis, interim disease-free survival (DFS) and overall survival (OS), and safety, after all patients completed/discontinued treatment. In this phase III, double-blind, placebo-controlled study, patients with treatment-naïve R-NSCLC (stage II-IIIB [N2]) were randomly assigned (1:1) to neoadjuvant platinum-based chemotherapy plus durvalumab/placebo (once every 3 weeks, four cycles) presurgery and then adjuvant durvalumab/placebo (once every 4 weeks, 12 cycles). Efficacy was analyzed in the modified intention-to-treat population (n = 740; for DFS, its resected subpopulation), which excluded patients with documented EGFR/ALK aberrations. As of May 10, 2024 (median follow-up, 25.9 months [censored patients]), EFS benefit favoring the durvalumab arm remained consistent (hazard ratio [HR], 0.69 [95% CI, 0.55 to 0.88]). Numerical improvement in DFS (HR, 0.66 [95% CI, 0.47 to 0.92]) and OS (HR, 0.89 [95% CI, 0.70 to 1.14]) favored the durvalumab arm. Maximum grade 3/4 adverse events occurred in 15.4% and 10.6% of the durvalumab and placebo arms, respectively, during adjuvant treatment. These results further support perioperative durvalumab plus neoadjuvant chemotherapy as a new treatment option.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.