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Clinical Trial
. 2020 Oct 29;383(18):1711-1723.
doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer

Yi-Long Wu  1 , Masahiro Tsuboi  1 , Jie He  1 , Thomas John  1 , Christian Grohe  1 , Margarita Majem  1 , Jonathan W Goldman  1 , Konstantin Laktionov  1 , Sang-We Kim  1 , Terufumi Kato  1 , Huu-Vinh Vu  1 , Shun Lu  1 , Kye-Young Lee  1 , Charuwan Akewanlop  1 , Chong-Jen Yu  1 , Filippo de Marinis  1 , Laura Bonanno  1 , Manuel Domine  1 , Frances A Shepherd  1 , Lingmin Zeng  1 , Rachel Hodge  1 , Ajlan Atasoy  1 , Yuri Rukazenkov  1 , Roy S Herbst  1 ; ADAURA Investigators
Collaborators, Affiliations
Clinical Trial

Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer

Yi-Long Wu et al. N Engl J Med. .

Abstract

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.).

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