Osimertinib conferred a statistically significant and clinically meaningful improvement in OS compared with placebo among patients with early-stage EGFR-mutated non-small cell lung cancer, according to the agent’s manufacturer.

Results of randomized, phase 3 ADAURA trial showed the survival benefit with osimertinib (Tagrisso, AstraZeneca), a third-generation, irreversible EGFR tyrosine kinase inhibitor, among patients who underwent complete tumor resection with curative intent.

The ADAURA trial included 682 patients with stage IB, stage II or stage IIIA EGFR-mutated NSCLC who received adjuvant treatment with 80 mg osimertinib orally once a day or placebo for 3 years or until disease recurrence.

DFS among patients with stage II and stage IIIA disease served as the primary endpoint. Key secondary endpoints included DFS among stage IB, stage II and stage IIIA patients, as well as OS in both the primary and overall populations.

Results released in September showed median DFS of nearly 5 and a half years, according to an AstraZeneca press release.