Adjuvant osimertinib resulted in significantly longer disease-free survival when compared with placebo in patients with stage IB to IIIA EGFR-mutation–positive non-small cell lung cancer (NSCLC), according to phase 3 results of the ADAURA trial.
The trial randomly assigned 682 patients to receive osimertinib 80 mg once daily or placebo for 3 years. All patients had completely resected EGFR-positive disease.
At 2 years, twice as many patients with stage II to IIIA disease in the osimertinib group were alive and disease-free as in the placebo group (80% vs 44%; hazard ratio [HR], 0.17; 99.06% CI, 0.11-0.26). Among the whole population, 89% of patients assigned osimertinib were alive and disease-free at 2 years compared with 52% of those assigned placebo (HR, 0.20; 99.12% CI, 0.14-0.30; P <.001).
“The disease-free survival benefit with osimertinib was observed consistently across all predefined subgroups, including all disease stages,” the researchers wrote. Based on these data, they concluded that “osimertinib as adjuvant therapy is an effective new treatment strategy for these patients after complete resection.”
Overall survival data are immature. No new safety concerns for osimertinib were noted in the trial.
Wu Y-L, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2020;383:1711-1723. doi:10.1056/NEJMoa2027071