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Publications

Journal Article Ahead of print 3 citations

PubMed: 42664473 DOI: 10.1200/JCO-25-02659

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

J Clin Oncol

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

Affiliations

  • Department of Thoracic/Head and Neck Medical Oncology, The University of Texas, M.D. Anderson Cancer Center, Houston, TX.
  • Thoracic Surgery Department, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Department of Surgery, Duke University Medical Center, Durham, NC.
  • Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
  • Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins Kimmel Cancer Center, Baltimore, MD.
  • Mátraháza University and Teaching Hospital, Mátraháza, Hungary.
  • Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
  • Orlandi Oncologia, Providencia, Chile.
  • Oncology Center, Medica Sur Hospital, Mexico City, Mexico.
  • Alicante University Hospital Isabial, Alicante, Spain.
  • University Hospital of Santiago de Compostela, Santiago, Spain.
  • Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
  • Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy.
  • Cross Cancer Institute, Edmonton, AB, Canada.
  • Department of Oncology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.
  • General Thoracic Surgery, Kawasaki Medical School, Okayama, Japan.
  • Törökbalint Institute of Pulmonology, Törökbálint, Hungary.
  • Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.
  • Department of Hematology, Oncology, Gastroenterology and Infectiology, Landeskrankenhaus Feldkirch, Feldkirch, Austria.
  • Krasnoyarsk State Medical University, Krasnoyarsk, Russia.
  • Fundación Estudios Clínicos, Santa Fe, Argentina.
  • Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
  • Koranyi National Institute for TB and Pulmonology, Budapest, Hungary.
  • Oncology and Chemotherapy Department, University Medical Center of HCMC, Ho Chi Minh City, Vietnam.
  • Department of Lung Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
  • Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
  • Clinical Oncology Unit, Careggi University Hospital, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
  • Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
  • Tata Medical Center, Kolkata, West Bengal, India.
  • Virginia Cancer Specialists Research Institute, Fairfax, VA.
  • US Oncology Research, The Woodlands, TX.
  • Duke Cancer Institute, Durham, NC.
  • No. 1 Medical Oncology Department, Hanoi Oncology Hospital, Hanoi, Vietnam.
  • AstraZeneca, Cambridge, United Kingdom.
  • AstraZeneca, New York, NY.
  • Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.

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.

MeSH

Cells, Lung, Disease-Free Survival, Safety, Neoplasms, Carcinoma, Non-Small-Cell Lung, Drug Therapy, Lung Neoplasms, Small Cell Lung Carcinoma, Therapeutics, Medical Oncology, Chemotherapy