ADAURA: Final OS analysis reinforced adjuvant osimertinib as the standard of care for patients with resected EGFR-mutated stage IB-IIIA NSCLC

The final data from a randomized, double-blind, phase III ADAURA study presented at the 2023 ASCO Annual Meeting showed that osimertinib significantly and clinically meaningfully improved overall survival (OS) versus placebo in patients with resected EGFR-mutated stage IB–IIIA non-small cell lung cancer (NSCLC).1,2 More specifically, at a median follow-up of around 61 months, osimertinib was associated with a 51% reduction in the risk of death (HR: 0.49 [95.03% CI: 0.33−0.73]; p=0.0004) in the subset of patients with stage II/IIIA disease. The 60-month OS rates were 85% in the osimertinib and 73% in the placebo arm. These results follow the primary analysis in 2020 that demonstrated significantly extended disease-free survival (DFS) with osimertinib versus placebo (HR: 0.17 [99.06% CI: 0.11−0.26]; p<0.001).3 Based on these data, osimertinib is positioned as the standard of care therapy for metastatic disease that prolongs survival in this patient population and may even offer a cure for some patients. Indeed, targeted therapy for early-stage disease is a new paradigm for lung cancer.