An 8-year update of the phase III ADAURA trial showed that adjuvant osimertinib continued to demonstrate an overall survival benefit over placebo in patients with resected EGFR-mutated non–small cell lung cancer (NSCLC), according to findings presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC; Abstract PL03.01), and published in the Journal of Thoracic Oncology.
“These additional long-term findings further characterize the established survival benefit of adjuvant osimertinib for patients with resected EGFR-mutated stage IB–IIIA NSCLC, with or without adjuvant chemotherapy,” said Roy S. Herbst, MD, PhD, Director of Dartmouth Cancer Center. “This is the first study to establish the new paradigm that bringing the best targeted drugs to patients with earlier-stage disease can delay progression and improve survival. We have come such a long way in the 30 years since EGFR inhibitors were first introduced into clinical practice, and this is great news for our patients.”
Background and Study Methods
The global, double-blind, randomized phase III ADAURA trial explored the use of adjuvant osimertinib vs placebo in patients with resected EGFR-mutated stage IB–IIIA NSCLC. The study showed a significant benefit in disease-free survival and overall survival for those who received adjuvant osimertinib over placebo.
A post hoc exploratory analysis explored the long-term overall survival of patients in the ADAURA study. For the analysis, patients were followed yearly or information was gathered from accessible records from their last contact date after the planned final overall survival analysis.
If no additional long-term overall survival data were available, the patients remained censored at their last known alive date (n = 127).
Key Findings
In the primary population of patients with stage II–IIIA disease, the hazard ratio (HR) for overall survival was 0.53 (95% confidence interval [CI] = 0.38–0.75), favoring osimertinib. At 8 years, the overall survival rate was 74% (95% CI = 67%–80%) with adjuvant osimertinib vs 58% (95% CI = 50%–65%) with placebo. The median follow-up was 92 months in the osimertinib arm and 68.5 months in the placebo arm.
In the overall population, the HR for overall survival was 0.52 (95% CI = 0.39–0.71), and the 8-year rates were 79% (95% CI = 74%–83%) and 64% (95% CI = 58%–70%) with osimertinib and placebo, respectively.
Overall survival benefit favoring osimertinib was also observed across prespecified subgroups.
DISCLOSURES: For full disclosures of the study authors, visit abstractsonline.com.
