Multicenter phase 3 study of first-line limertinib versus gefitinib for locally advanced or metastatic NSCLC with EGFR-sensitizing mutation

Limertinib is a new third-generation EGFR TKI. A phase 3 trial at 56 centers in China compared first-line limertinib versus first-line gefitinib for locally advanced or metastatic NSCLC with EGFR ex19del or ex21 L858R mutation. Independent central review-assesed progression-free survival was 20.7 months in the limertinib group versus 9.7 months in the gefitinib group (HR 0.44; p<0.0001). Treatment-related adverse events of grade 3 or worse occurred in 25% of patients in each group. The authors conclude that limertinib should be considered as another first-line treatment option for this patient population.