ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer
After surgery for early-stage EGFR-mutated lung cancer, three years of osimertinib cut recurrences by about 80% and later reduced deaths by half.
Double-blind, placebo-controlled phase 3 trial of 682 patients with completely resected stage IB-IIIA EGFR-mutated NSCLC, with or without adjuvant chemotherapy, randomised to three years of osimertinib or placebo. Primary endpoint was disease-free survival in stage II-IIIA.
The trial was unblinded early: DFS HR 0.17 in stage II-IIIA and 0.20 overall, with 24-month DFS 89% vs 52%. The 2023 overall survival report showed 5-year OS 88% vs 78% (HR 0.49). It made adjuvant osimertinib standard and established EGFR testing of resected tumours.
- Stage II-IIIA: 24-month disease-free survival 90% vs 44%; HR 0.17 (99.06% CI 0.11-0.26).
- Overall population (IB-IIIA): 24-month DFS 89% vs 52%; HR 0.20.
- CNS recurrence or death HR 0.18.
- Overall survival (2023): 5-year OS 88% vs 78% overall, HR 0.49; stage II-IIIA 85% vs 73%.
- Benefit was seen with or without prior adjuvant chemotherapy.
Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
- Early unblinding after a dramatic DFS effect meant the trial was stopped before the planned analysis.
- Recurrences resumed after osimertinib stopped, raising the question of whether it delays rather than prevents relapse in some patients; OS benefit argues it does more than delay.
- Optimal duration (three years vs indefinite) is untested.
- Cost of three years of therapy is very high.
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