The FDA has approved osimertinib (Tagrisso) for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
The regulatory decision was based on data from the double-blind, placebo-controlled, phase 3 ADAURA trial (NCT02511106), which showed that osimertinib, when used as an adjuvant therapy, led to a statistically significant improvement in disease-free survival in patients with stage IB/II/IIIA EGFR-mutated NSCLC. The agent resulted in a 79% reduction in the risk of disease recurrence or death (HR, 0.21; 95% CI, 0.16-0.28; P <.0001).
A total of 682 patients with EGFR exon 19 deletions or exon 21 L858R mutations were randomized 1:1 to receive osimertinib at either 80 mg orally once daily or placebo following recovery from surgery and standard adjuvant chemotherapy, if given.
Additional data presented during the 2020 ASCO Virtual Scientific Program showed that the median DFS in the subset of patients with stage II/IIIA disease had not yet been reached in the osimertinib arm versus 20.4 months in the placebo arm (HR, 0.17; 95% CI, 0.12-0.23; P <.0001). Notably, the DFS benefit proved to favor osimertinib across all subgroups analyzed.
The 2-year DFS rates with osimertinib versus placebo in those with stage IB disease were 87% versus 73% (HR, 0.50; 95% CI, 0.25-0.96), respectively; these rates were 91% versus 56%, respectively, in those with stage II disease (HR, 0.17; 95% CI, 0.08-0.31) and 88% versus 32%, respectively, in those with stage IIIA disease (HR, 0.12; 95% CI, 0.07-0.20).
The OS data are still immature, at just 5% maturity, and the median OS has not yet been reached in either arm (HR, 0.40; 95% CI, 0.18-0.90).
This article was originally published on OncLive as, "FDA Approves Adjuvant Osimertinib for EGFR+ NSCLC."