Perioperative Durvalumab for Resectable Non-Small Cell Lung Cancer: Updated Outcomes From the Phase III AEGEAN Trial.

Authors

John V Heymach, Jie He, David Harpole, Tetsuya Mitsudomi, Janis M Taube, Shugeng Gao, Laszlo Urban, Jin Hyoung Kang, Francisco J Orlandi, Jeronimo Rodriguez-Cid, Bartomeu Massuti, Luis Leon Mateos, Giulia Pasello, Quincy Chu, Jaroslaw Kolb-Sielecki, Masao Nakata, Gabriella Galffy, Maximilian Hochmair, Thomas Winder, Ruslan Zukov, Gabriel Garbaos, Yoshitsugu Horio, Gyula Ostoros, Tho V Tran, Jian You, Kang-Yun Lee, Lorenzo Antonuzzo, Hiroaki Akamatsu, Bivas Biswas, Alexander Spira, Jeffrey Crawford, Ha T Le, Mike Aperghis, Helen Mann, Tamer M Fouad, Gary J Doherty, Martin Reck

Published in

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. Pages JCO2502659. Aug 28, 2026. Epub Aug 28, 2026.

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.

PMID:
42664473
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

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