1O Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non-small cell lung cancer: A randomized, double-blind, multi-center, phase III study (FURLONG)

Abstract

Furmonertinib (AST2818) is an irreversible, selective third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This study aimed to compare the efficacy and safety of furmonertinib versus gefitinib in untreated advanced non-small cell lung cancer (NSCLC) patients with EGFR sensitizing mutations. FURLONG was a randomized, double-blind, phase III study conducted in 55 centers across mainland China. Stage IIIB/IIIC/IV NSCLC patients with EGFR Ex19Del or L858R mutation positive were enrolled to receive either furmonertinib 80 mg/d or gefitinib 250 mg/d as first-line therapy. The primary endpoint was progression-free survival (PFS) assessed by an independent review center (IRC). Between May 30, 2019 and Dec 5, 2019, 358 patients were randomized to receive furmonertinib (n=178) or gefitinib (n=180) treatment. In the furmonertinib and gefitinib groups, 35% and 32% had central nervous system (CNS) metastases at baseline, respectively. As of Sep 15 2021, the median follow-up was both 21.0 months in each group. The median PFS with furmonertinib was significantly longer than with gefitinib (20.8 versus 11.1 months; HR 0.44 [95%CI 0.34-0.58]; p<0.0001). The clinical benefit of PFS was consistent across all pre-specified subgroups including patients with CNS metastases (HR 0.50 [95%CI 0.32-0.80]). The median duration of exposure was 18.3 months in the furmonertinib group and 11.2 months in the gefitinib group, whereas the frequency of grade≥3 treatment-related adverse events (TRAEs) was 11% in the furmonertinib group and 18% in the gefitinib group. Furmonertinib significantly prolonged PFS and showed less grade≥3 TRAEs compared with gefitinib as first-line treatment in advanced EGFR mutated NSCLC patients.