Multinational phase 3 trial of osimertinib after chemoradiotherapy for unresectable stage III EGFR-mutated non-small cell lung cancer

The multinational phase 3 LAURA trial compared osimertinib versus placebo for patients without progression after chemoradiotherapy for unresectable EGFR-mutated stage III non-small cell lung cancer. The primary endpoint was progression-free survival by blinded independent central review. The median PFS was 39.1 months with osimertinib versus 5.6 months with placebo (HR 0.16; p<0.001), with 12-months PFS rate of 74% versus 22%. Interim overall survival data (20% maturity) showed 36-month OS among 84% of patients with osimertinib and 74% among patients with placebo (HR 0.81; p=0.53). Incidence of grade 3 of higher adverse events was 35% in the osimertinib group and 12% in the placebo group. No new safety concerns emerged. The authors conclude that treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC.