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.

Conflict of interest

The author reports consulting roles with AbbVie Pharmaceuticals, ARMO Biosciences, AstraZeneca, Biodesix, Bolt Biotherapeutics, Bristol Myers Squibb, Cybrexa Therapeutics, eFFECTOR Therapeutics, Eli Lilly, EMD Serono, Genentech/Roche, Genmab, Halozyme Therapeutics, Heat Biologics, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Loxo Oncology, Merck, Mirati Therapeutics, Nektar, Neon Therapeutics, NextCure, Novartis, Oncternal Therapeutics, Pfizer, Sanofi, Seattle Genetics, Shire, Spectrum Pharmaceuticals, STCube Pharmaceuticals, Symphogen, Takeda, Tesaro, Tocagen and WindMIL Therapeutics; advisory board roles with AstraZeneca, Bolt Biotherapeutics, Cybrexa Therapeutics, EMD Serono, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Neon Therapeutics, Novartis and STCube Pharmaceuticals; research support from AstraZeneca, Eli Lilly, Genentech/Roche and Merck; and non-executive board membership for Junshi Pharmaceuticals and Immunocore.

Funding

The author has declared that no financial support was received from any organization for the submitted work.

Author Contributions

The author created and approved the final manuscript.