Abstract 658P
Background
NSCLC patients with EGFR L858R mutation show poor outcomes in terms of response and survival rates compared with EGFR 19Del. Several therapeutic strategies have been proposed to improve the clinical outcomes of EGFR L858R patients, including combination therapy of EGFR-TKI plus antiangiogenic agents or chemotherapy and high-dose EGFR-TKI, etc. Furmonertinib, as a third-generation EGFR-TKI, is preferred for first-line treatment of advanced EGFR-mutated NSCLC and its 160mg studies have also showed well-tolerated safety profile in this population. Therefore, a multicencer, open-label, single-arm phase II study was conducted to explore furmonertinib 160mg as first-line treatment for advanced NSCLC patients with EGFR L858R mutation.
Methods
Patients with treatment naive locally advanced or metastatic NSCLC harboring EGFR exon 21 L858R mutation were enrolled. Patients with stable CNS metastases were eligible. Regimen was furmonertinib 160mg p.o, qd. Primary endpoint was PFS. Secondary endpoints were ORR, DCR, OS, safety, etc.
Results
Between September 2022 and November 2023, 33 patients were enrolled in 4 centers and treated with furmonertinib 160mg. The median age was 65 years (range 47–80), female (51.5%), ECOG PS 1 (100%), never smokers (66.7%), stage IV adenocarcinoma (90.9%). At data cutoff (July 01 2024), median follow-up was 14.7 months, treatment is ongoing in 21 patients and the longest exposure was 21.7 months. Preliminary efficacy results: ORR was 75.8% (95%CI, 57.70% to 88.9%), DCR was 87.9% (95%CI, 71.8% to 96.6%), one-year PFS rate was 81% assessed by the investigators according to RECIST1.1 criteria, median PFS was not reached. Two (6.1%) patients experienced grade 3 or more TEAE, which resulted in dose interruptions. No grade 5 TEAE was reported. No dose reduction or treatment discontinuation due to TEAE was reported.
Conclusions
Furmonertinib 160mg as first-line treatment showed encouraging efficacy and well-tolerated safety profile for advanced NSCLC patients with EGFR exon 21 L858R mutation. This study is still ongoing and further analyses of longer-term outcomes will be evaluated, which may provide a new treatment option for this population.
Clinical trial identification
ChiCTR2200060897.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Shanghai Allist Pharmaceuticals Co., Ltd, Shanghai, China.
Disclosure
All authors have declared no conflicts of interest.