Post hoc exploratory analysis of long-term overall survival (OS) from the ADAURA phase III trial, evaluating adjuvant osimertinib vs. placebo in resected EGFR-mutated stage IB–IIIA NSCLC (N=682) with up to ~8 years of follow-up (DCO: 4 May 2026).
In stage IB–IIIA patients, 8-year OS was 79% (osimertinib) vs. 64% (placebo), HR 0.52 (95% CI: 0.39–0.71); in stage II–IIIA, 74% vs. 58%, HR 0.53 (95% CI: 0.38–0.75). Benefit was strongest in Ex19del (HR 0.45; 95% CI: 0.29–0.68) vs. L858R (HR 0.72; 95% CI: 0.46–1.11, crossing 1).
- Post hoc exploratory design; not a pre-specified analysis, limiting inferential strength. - 127 patients (alive at the planned final OS analysis) had no additional follow-up and remained censored, potentially underestimating survival differences. - Data collection relied partly on accessible records or last-contact information, introducing potential ascertainment bias.
Adjuvant osimertinib confers a durable, clinically meaningful OS benefit at 8 years, particularly in stage II–IIIA and Ex19del EGFR-mutated NSCLC — reinforcing its role as standard-of-care adjuvant therapy. Clinicians should note the weaker OS signal for L858R mutations (HR 0.72; CI crosses 1), which may warrant further individualized discussion.
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