Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB–IIIA NSCLC: Exploratory 8-Year Overall Survival Landmark Update from the ADAURA Trial
Year: 2026
Type: article
Abstract: INTRODUCTION: In ADAURA, adjuvant osimertinib improved disease-free survival (DFS) and overall survival (OS) compared with placebo in patients with resected epidermal growth factor receptor (EGFR)-mutated stage IB-IIIA NSCLC. We report a post hoc exploratory analysis of long-term OS after adjuvant treatment completion. METHODS: Patients (N = 682) were randomized to osimertinib or placebo until recurrence, treatment completion, or discontinuation. Updated survival data were collected from 431 of 558 patients alive at the planned final OS analysis (data cutoff [DCO], January 27, 2023) through yearly follow-up until the current DCO (May 4, 2026) or from accessible records or information from the last contact date after January 27, 2023. Patients without additional follow-up remained censored, with survival time unchanged from the planned final OS analysis DCO (n = 127). This exploratory long-term OS analysis was conducted in all randomized patients. RESULTS: At the current DCO, in the stage II-IIIA population, the OS hazard ratio (HR) was 0.53 (95% confidence interval [CI]: 0.38-0.75); the 8-year OS rates were 74% (osimertinib) versus 58% (placebo); the median follow-up was 92.0 versus 68.5 months. In the stage IB-IIIA population, the OS HR was 0.52 (95% CI: 0.39-0.71); the 8-year OS rates were 79% (osimertinib) versus 64% (placebo); the median follow-up was 93.3 versus 79.6 months. The OS HRs according to EGFR Ex19del and L858R mutations were 0.45 (95% CI: 0.29-0.68) and 0.72 (95% CI: 0.46-1.11), respectively. An OS benefit with osimertinib was observed across subgroups. CONCLUSION: With the longest OS from a global phase III adjuvant trial in EGFR-mutated stage IB-IIIA NSCLC, these additional long-term results further characterize the established survival benefit of adjuvant osimertinib. CLINICAL TRIAL INFORMATION: ADAURA (NCT02511106).
Source: Journal of Thoracic Oncology
Authors: Yi-Long Wu, Margarita Majem, Thomas John, Christian Grohé, Jie Wang, Jonathan W. Goldman, Shun Lu, Frances A. Shepherd, Qun Wang, Terufumi Kato, Keiju Aokage, Wen-Zhao Zhong, Konstantin Laktionov, Ming-Fang Wu, Charuwan Akewanlop, Huu Vinh Vu, Ki Hyeong Lee, Xiangning Huang, Elena Armenteros-Monterroso, Yuri Rukazenkov, Roy S. Herbst
Institutions: Guangdong Academy of Medical Sciences, Guangdong Provincial People's Hospital, Southern Medical University, Hospital de Sant Pau, Institut de Recerca Sant Pau, The University of Melbourne, Peter MacCallum Cancer Centre, Evangelische Lungenklinik Berlin, Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, University of California, Los Angeles, Shanghai Jiao Tong University, Shanghai Chest Hospital, University Health Network, Princess Margaret Cancer Centre, Fudan University, Zhongshan Hospital, Kanagawa Cancer Center, National Cancer Center Hospital East, Ministry of Health of the Russian Federation, Chung Shan Medical University Hospital, Siriraj Hospital, Cho Ray Hospital, Chungbuk National University, Chungbuk National University Hospital, AstraZeneca (United Kingdom), AstraZeneca (Spain), Dartmouth Cancer Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,100
Funder: AstraZeneca
OpenAlex ID: W7212446011