Updated results from the Phase III ADAURA trial showed a sustained overall survival benefit with adjuvant osimertinib in patients with completely resected, early-stage EGFR-mutated non-small cell lung cancer (NSCLC), with nearly 80% of patients in the overall study population alive at eight years.
The exploratory long-term analysis was presented during the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, Republic of Korea, and simultaneously published in the Journal of Thoracic Oncology.
79% of Patients Alive at Eight Years
In the overall population of patients with Stage IB–IIIA EGFR-mutated NSCLC, 79% of those who received osimertinib were estimated to be alive at eight years, compared with 64% of patients who received placebo.
Osimertinib was associated with a 48% reduction in the risk of death compared with placebo in this population, with a hazard ratio of 0.52 (95% CI, 0.39–0.71).
Among patients with Stage II–IIIA disease, which represented the trial’s primary population, the estimated eight-year overall survival rate was 74% with osimertinib versus 58% with placebo. The risk of death was reduced by 47% (HR 0.53; 95% CI, 0.38–0.75).
The overall survival benefit was observed across predefined patient subgroups and remained consistent with the findings of the previously reported planned final overall survival analysis.
Roy S. Herbst, MD, PhD, Director of Dartmouth Cancer Center and principal investigator of ADAURA, commenting on the findings, said:
“These ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib.”
Herbst also highlighted the magnitude of the survival difference despite patients initially assigned to placebo being able to receive osimertinib after disease recurrence, and emphasized the importance of identifying EGFR mutations at diagnosis.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said the results represented another long-term milestone for ADAURA, highlighting that nearly four in five patients treated with adjuvant osimertinib were alive eight years after randomization. She said the findings further support early treatment and the role of osimertinib in EGFR-mutated lung cancer.
Long-Term Follow-Up of ADAURA
ADAURA (NCT02511106) is a randomized, double-blind, placebo-controlled Phase III trial evaluating adjuvant osimertinib in patients with completely resected Stage IB–IIIA EGFR-mutated NSCLC, with or without prior adjuvant chemotherapy.
A total of 682 patients were randomized to receive osimertinib 80 mg once daily or placebo for up to three years or until disease recurrence or another discontinuation criterion was met.
The primary endpoint was disease-free survival in patients with Stage II–IIIA disease. Key secondary endpoints included disease-free survival in the overall Stage IB–IIIA population and overall survival. The study enrolled patients at more than 200 centers across more than 20 countries.
For the new exploratory analysis, the data cutoff was May 4, 2026. Complete or partial extended survival information was available for approximately 77% of patients who were still alive at the time of the previous final overall survival analysis. For 127 patients without additional survival information, survival times remained censored at their previously recorded time points.
TP53 Gain-of-Function Mutations May Signal Early Osimertinib Resistance in EGFR-Mutant NSCLC
Survival Benefit Remains Years After Treatment
The new results extend earlier findings from ADAURA.
In the planned final overall survival analysis published in The New England Journal of Medicine in 2023, the five-year overall survival rate among patients with Stage IB–IIIA disease was 88% with osimertinib compared with 78% with placebo, corresponding to a 51% reduction in the risk of death.
Among patients with Stage II–IIIA disease, five-year overall survival was 85% with osimertinib and 73% with placebo.
The eight-year analysis therefore provides longer-term evidence that the separation in overall survival between the treatment groups persists years after completion of the planned three-year course of adjuvant therapy.
Safety and Treatment Duration
Final safety data for ADAURA were collected during the planned final overall survival analysis. According to AstraZeneca, the safety and tolerability profile of osimertinib remained consistent with its established profile, with no new safety signals identified.
Separate real-world evidence presented at WCLC 2026 evaluated US patients with Stage I–IIIA EGFR-mutated NSCLC receiving adjuvant osimertinib. According to AstraZeneca, discontinuing treatment before completing the established three-year course was associated with more than twice the risk of disease recurrence or death.
The findings add to the long-term ADAURA data supporting molecular testing for EGFR mutations in patients with resectable NSCLC and the use of targeted adjuvant therapy in eligible patients.
Read further updates from WCLC 2026: Trastuzumab Deruxtecan Improves PFS in First-Line HER2-Mutant NSCLC in DESTINY-Lung04
