Dacomitinib With or Without Dose Titration in Treatment-Naive Advanced EGFR-Mutated NSCLC - Primary Analysis of the ATORG-003 Phase 2 Trial

Introduction

Dacomitinib is an approved second-generation EGFR tyrosine kinase inhibitor. In the phase 3 ARCHER 1050 trial, both progression-free survival (PFS) and overall survival (OS) were improved with first-line dacomitinib compared with gefitinib. Post hoc analysis revealed that efficacy (PFS, OS) was similar in both dose-reduced patients and the overall study population. ATORG-003 evaluated a dose-titration strategy to improve tolerability while maintaining efficacy. This is also the first prospective study of dacomitinib's intracranial efficacy and resistance (tissue and plasma next-generation sequencing).