Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA Non-Small Cell Lung Cancer: Exploratory 8-year Overall Survival Landmark Update from the ADAURA Trial [161/175].

INTRODUCTION In ADAURA, adjuvant osimertinib improved DFS and OS versus placebo in resected EGFR-mutated stage IB-IIIA NSCLC. We report a post hoc exploratory analysis of long-term OS post-adjuvant treatment completion.

Methods

Patients (N = 682) were randomized to osimertinib or placebo until recurrence, treatment completion, or discontinuation. Updated survival data were collected from 431/558 patients alive at the planned final OS analysis (DCO, 27 January 2023) through yearly follow-up until the current DCO (4 May 2026) or from accessible records/information from last contact date after 27 January 2023. Patients without additional follow-up remained censored, survival time unchanged from the planned final OS analysis DCO (n = 127). This exploratory long-term OS analysis was conducted in all randomized patients.

Results

At the current DCO, in the stage II-IIIA population: OS HR was 0.53 (95% CI: 0.38-0.75); 8-year OS rates were 74% (osimertinib) versus 58% (placebo); median follow-up was 92.0 versus 68.5 months. In the stage IB-IIIA population: OS HR was 0.52 (95% CI: 0.39-0.71); 8-year OS rates were 79% (osimertinib) versus 64% (placebo); median follow-up was 93.3 versus 79.6 months. OS HRs according to EGFR Ex19del and L858R mutations were 0.45 (95% CI: 0.29-0.68) and 0.72 (95% CI: 0.46-1.11), respectively. OS benefit with osimertinib was observed across subgroups.

Conclusions

With the longest OS from a global phase III adjuvant trial in EGFR-mutated stage IB-IIIA NSCLC, these additional long-term results further characterize the established survival benefit of adjuvant osimertinib. CLINICAL TRIAL INFORMATION ADAURA (NCT02511106).