[HTML][HTML] Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
New England Journal of Medicine, 2020•Mass Medical Soc
Background Osimertinib is standard-of-care therapy for previously untreated epidermal
growth factor receptor (EGFR) mutation–positive advanced non–small-cell lung cancer
(NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown. Methods
In this double-blind, phase 3 trial, we randomly assigned patients with completely resected
EGFR mutation–positive NSCLC in a 1: 1 ratio to receive either osimertinib (80 mg once
daily) or placebo for 3 years. The primary end point was disease-free survival among …
growth factor receptor (EGFR) mutation–positive advanced non–small-cell lung cancer
(NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown. Methods
In this double-blind, phase 3 trial, we randomly assigned patients with completely resected
EGFR mutation–positive NSCLC in a 1: 1 ratio to receive either osimertinib (80 mg once
daily) or placebo for 3 years. The primary end point was disease-free survival among …
Background
Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation–positive advanced non–small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.
Methods
In this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR mutation–positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety.
Results
A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001). In the overall population, 89% of the patients in the osimertinib group (95% CI, 85 to 92) and 52% of those in the placebo group (95% CI, 46 to 58) were alive and disease-free at 24 months (overall hazard ratio for disease recurrence or death, 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). At 24 months, 98% of the patients in the osimertinib group (95% CI, 95 to 99) and 85% of those in the placebo group (95% CI, 80 to 89) were alive and did not have central nervous system disease (overall hazard ratio for disease recurrence or death, 0.18; 95% CI, 0.10 to 0.33). Overall survival data were immature; 29 patients died (9 in the osimertinib group and 20 in the placebo group). No new safety concerns were noted.
Conclusions
In patients with stage IB to IIIA EGFR mutation–positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.)
The New England Journal Of Medicine