A study of high dose furmonertinib in EGFR exon 20 insertion mutation-positive advanced non-small cell lung cancer

Background The epidermal growth factor receptor (EGFR) ex20ins mutation, as a rare subtype of mutation, has gradually attracted attention. Its heterogeneity is high, its prognosis is extremely poor, and the efficacy of existing traditional treatment plans is limited. In this study, we aimed to evaluate efficacy of high dose furmonertinib as a first-line treatment for EGFR ex20ins-positive NSCLC. Methods This is a retrospective, multi-center, non-interventional study. From May 2021 to March 2023, 9 NSCLC patients with EGFR ex20ins were enrolled. Efficacy and safety of 160 mg furmonertinib were evaluated. Objective response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and treatment related adverse events (TRAEs) were assessed. Results Of the evaluated patients, six patients experienced partial remission (PR), two patients experienced stable disease (SD) and one patient experienced progress disease (PD). Data indicated 66. 7% ORR and 88. 9% DCR. The median progression free survival (PFS) was 7. 2 months (95% CI: 6. 616 - 7. 784). Besides, a longgest PFS with 18 months was found in one patient with p. H773V774insGTNPH mutation. No ≥ level 3 adverse events have been found. Conclusions The study proved the potential efficacy of 160mg furmonertinib in patients with advanced NSCLC with EGFR ex20ins. Meanwhile, 160mg furmonertinib had a good safety profile.