Osimertinib for Untreated EGFR-Mutated Advanced NSCLC

Investigators have conducted a randomized, double-blind, phase III trial (FLAURA) to compare the safety and efficacy of the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib with standard-of-care first-generation EGFR TKIs erlotinib or gefitinib in 556 untreated patients with EGFR-mutated non–small-cell lung cancer (NSCLC). All patients had sensitive EGFR mutations (deletion exon 19 or L858R), and about one quarter had central nervous system (CNS) metastases at baseline.

Objective response rates were similar with osimertinib versus erlotinib or gefitinib (80% and 76%, respectively). However, the median duration of response was prolonged with osimertinib (17.2 vs. 8.5 months), as was median p…