Osimertinib ( Tagrisso ) 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.
In a double-blind, phase 3 trial, AUDARA, researchers have 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.
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 less than 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 less than 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.
In conclusion, in patients with stage IB to IIIA EGFR mutation–positive non–small-cell lung cancer, disease-free survival was significantly longer among those who received Osimertinib than among those who received placebo. ( Xagena )
Wu YL et al, N Engl J Med 2020; 383: 1711-1723