Multicenter phase 3 trial of first-line befotertinib versus icotinib for EGFR-mutated locally advanced or metastatic non-small cell lung cancer

Befotertinib is a novel, oral third-generation EGFR-TKI. A multicenter phase 3 trial in China compared first-line befotertinib versus icotinib for EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (LA/M NSCLC). The median independent review committee-assessed progression-free survival was 22.1 months with befotertinib versus 13.8 months with icotinib (HR 0.49; p<0.0001). Grade 3 or higher treatment-related adverse events were more frequent with befotertinib. Two (1%) patients in the befotertinib group and one (1%) patient in the icotinib group died due to TRAEs. The authors conclude that befotertinib demonstrated superior efficacy compared with icotinib in first-line treatment of EGFR mutation-positive LA/M NSCLC. The safety profile of befotertinib was manageable.