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Eight years after surgery, about three in four patients who took osimertinib for three years were still alive, compared with under six in ten on placebo: the longest survival follow-up from any global adjuvant trial in EGFR-mutated lung cancer.
Post hoc exploratory analysis of long-term overall survival in ADAURA, the phase 3 trial that randomised 682 patients with resected EGFR-mutated stage IB to IIIA non-small-cell lung cancer to three years of adjuvant osimertinib or placebo. Survival data were collected from 431 of the 558 patients alive at the planned final overall survival analysis (data cut-off 27 January 2023) through yearly follow-up to a new cut-off of 4 May 2026; the 127 patients without further follow-up stayed censored at the earlier cut-off.
In the stage II to IIIA population the overall survival hazard ratio was 0.53 (95 percent CI 0.38 to 0.75) and eight-year survival was 74 percent with osimertinib against 58 percent with placebo. In the stage IB to IIIA population the hazard ratio was 0.52 (95 percent CI 0.39 to 0.71) with eight-year survival of 79 percent against 64 percent. Hazard ratios by mutation were 0.45 for exon 19 deletions and 0.72 (95 percent CI 0.46 to 1.11) for L858R, and the benefit was seen across subgroups.
The survival benefit first reported in 2023 has held five years after the last dose of adjuvant osimertinib, which answers the worry that a three-year course only delays relapse. Patients with an exon 19 deletion gained most; the L858R estimate crosses one and is less certain. Nothing here changes the recommendation, which already rests on the 2023 analysis, but it tightens the case for testing every resected non-squamous tumour for EGFR mutations.
Shares Shun Lu, Yi-Long Wu, Roy S. Herbst, ADAURA.
Shares Shun Lu, Yi-Long Wu, ADAURA, Non-small-cell lung cancer.
Shares Osimertinib, Resectable stage I to III non-small-cell lung cancer, EGFR-mutated non-small-cell lung cancer, AstraZeneca.
Shares Resectable stage I to III non-small-cell lung cancer, EGFR-mutated non-small-cell lung cancer, EGFR, Non-small-cell lung cancer.
Shares Osimertinib, Resectable stage I to III non-small-cell lung cancer, AstraZeneca, Non-small-cell lung cancer.
Shares Osimertinib, Resectable stage I to III non-small-cell lung cancer, AstraZeneca, Non-small-cell lung cancer.
Shares Osimertinib, EGFR-mutated non-small-cell lung cancer, AstraZeneca, Non-small-cell lung cancer.
Shares Osimertinib, EGFR-mutated non-small-cell lung cancer, EGFR, AstraZeneca.