Abstract 162P
Background
Furmonertinib is a novel oral, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that has been shown to exhibit broad activity and selectivity against various mutations, including EGFR 20ins mutations, in NSCLC. With advancements in clinical research, furmonertinib has demonstrated good efficacy and tolerability in treating early-stage NSCLC patients. This study aims to retrospectively evaluate the efficacy and safety of furmonertinib in early-stage EGFR-mutated NSCLC patients, in real-world study.
Methods
This retrospective study included patients with stage I-IIIA EGFR-mutated lung adenocarcinoma who underwent surgery and received adjuvant furmonertinib (80 mg, qd) treatment at the First Affiliated Hospital of Zhejiang University School of Medicine. The primary endpoints were the 2-year DFS rate and the 2-year OS rate. Secondary endpoints included DFS, OS, and safety. DFS was defined from the time of surgery to disease progression or death, while OS was defined from the time of surgery to death from any cause.
Results
A total of 135 eligible patients were included in this study, including 59 with EGFR19+ and 76 with EGFR21+ mutations; 44 patients with stage IA2, 35 with stage IA3, 21 with stage IB, and 35 with stage II-IIIA. As of March 31, 2024, the median follow-up time was 31.6 months (95% CI: 30.6–32.6). Among the 135 patients, 15 experienced disease progression or death. The median DFS and OS for the overall population were not reached. The 1-year, 2-year, DFS rates were 95.6%, 91.1%, respectively, while the 1-year, 2-year, OS rates were 97.8%, 94.1%, respectively. In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was 39.6% (53/135), most of TEAE were grade 1–2, with a ≥3 grade TRAEs occurrence rate of 3.0% (4/135). Common TEAEs included rash (14.8%, 20/135), diarrhea (11.1%, 15/135), oral ulcer (8.9%, 12/135), hepatic injury (4.4%, 6/135), and chapped skin (3.7%,5/135) with no new safety events reported.
Conclusions
Furmonertinib demonstrates promising efficacy and manageable safety in the adjuvant treatment of early-stage NSCLC patients with EGFR mutations. Although the primary endpoint is still immature, the trial is ongoing and being continually followed up.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.