OSIMERTINIB demonstrated a sustained long-term overall survival (OS) benefit in patients with resected epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), with the latest ADAURA data showing higher 8-year survival rates than placebo. This data was presented at the IASLC 2026 World Conference on Lung Cancer.
The global Phase III, double-blind, randomised ADAURA trial evaluated adjuvant osimertinib in patients with completely resected EGFR-mutated stage IB–IIIA NSCLC. A total of 682 eligible patients were randomly assigned to once-daily osimertinib 80 mg or placebo, with adjuvant chemotherapy permitted.
All patients had completed, or had the opportunity to complete, 3 years of adjuvant study treatment. This post hoc exploratory analysis extended OS follow-up beyond the planned final analysis, using additional follow-up information collected through 4 May 2026.
The analysis included all randomised patients. Survival estimates were assessed using Kaplan–Meier methodology, while hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using stratified log-rank statistics.
Among patients with stage II–IIIA disease, which represented the primary population, osimertinib was associated with a lower risk of death than placebo (HR: 0.53; 95% CI: 0.38–0.75). The 8-year OS rate was 74% with osimertinib compared with 58% with placebo.
In the overall stage IB–IIIA population, the OS benefit was similarly maintained (HR: 0.52; 95% CI: 0.39–0.71). Eight-year OS was 79% with osimertinib versus 64% with placebo.
The survival benefit was observed across predefined patient subgroups. Median OS follow-up reached 93.3 months in the osimertinib group and 79.6 months in the placebo group in the overall population.
The updated findings provided additional evidence regarding the durability of adjuvant osimertinib after surgical resection of EGFR-mutated NSCLC. The data further characterised the established survival benefit of adjuvant osimertinib in patients with resected stage IB–IIIA EGFR-mutated NSCLC, regardless of whether patients also received adjuvant chemotherapy.
These long-term results added to the evidence supporting 3 years of adjuvant osimertinib in this population and demonstrated that the survival benefit remained evident with extended follow-up.
Reference
Herbst RS et al. PL03.01Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA NSCLC: ADAURA Exploratory 8-year Overall Survival Landmark Update. Abstract PL03.01. WCLC Congress; 12-15 September 2026.
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