Multicenter first-in-human phase 1-2 trial of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung cancer

FHND-9041 is a novel third-generation EGFR-TKI. A multicenter first-in-human phase 1-2 trial in China evaluated FHND-9041 monotherapy in patients with EGFR-mutated advanced non-small cell lung cancer (aNSCLC). In phase 1, no dose-limiting toxicity was observed. Phase 2 included treatment-naïve patients who received FHND-9041 at a dose of 80 mg once daily. The objective response rate was 62.2%, and the median progression-free survival was 15.5 months (95% CI 12.9-18.1). Treatment-related adverse events of grade 3 or 4 were decreased white blood cell count (11.3% of patients) and liver impairment (4.8%). The authors conclude that FHND-9041 exhibited favorable safety and efficacy, supporting its further clinical development for EGFR-mutated aNSCLC.