Central Nervous System Efficacy of Furmonertinib (AST2818) Versus Gefitinib as First-Line Treatment for EGFR-Mutated NSCLC: Results From the FURLONG Study

作者：Shi, Yuankai^*; Chen, Gongyan; Wang, Xiang; Liu, Yunpeng; Wu, Lin; Hao, Yanrong; Liu, Chunling; Zhu, Shuyang; Zhang, Xiaodong; Li, Yuping; Liu, Jiwei; Cao, Lejie; Cheng, Ying; Zhao, Hui; Zhang, Shucai; Zang, Aimin; Cui, Jiuwei; Feng, Jian; Yang, Nong; Liu, Fei; Jiang, Yong; Gu, Chuan

来源：Journal of Thoracic Oncology, 2022, 17(11): 1297-1305.

DOI：10.1016/j.jtho.2022.07.1143

• NSCLC
• EGFR
• Furmonertinib
• AST2818
• CNS

Introduction: Furmonertinib (AST2818) is a pan-EGFR tyrosine kinase inhibitor with central nervous system (CNS) antitumor activity. We report the CNS efficacy of furmo-nertinib compared with gefitinib in untreated EGFR-sensi-tizing mutation-positive NSCLC from the FURLONG study.Methods: FURLONG was a randomized, double-blind, phase 3 study conducted in 55 hospitals in the People's Republic of China. Patients 1:1 randomly received furmonertinib 80 mg once daily or gefitinib 250 mg once daily treatment. At screening, all the patients underwent brain imaging exam-ination. Patients with asymptomatic steady CNS metastases at baseline constituted this preplanned CNS subgroup analysis.Results: A total of 358 patients were enrolled in the FURLONG study. In the 133 (37%) patients who had measurable or nonmeasurable CNS lesions, CNS progression-free survival was 20.8 months (95% confi-dence interval [CI]: 15.2-25.3) in the furmonertinib group and 9.8 months (95% CI: 7.2-18.0) in the gefitinib group (hazard ratio = 0.40 [95% CI: 0.23-0.71], p = 0.0011). In the 60 patients (17%) who had measurable CNS lesions, CNS objective response rate was 91% (95% CI: 72-99) with furmonertinib and 65% (95% CI: 48-80) with gefitinib (OR = 6.82 [95% CI: 1.23-37.67], p = 0.0277). The least -square mean of CNS depth of response was 62% (95% CI: 51-72) in the furmonertinib group and 39% (95% CI: 30- 47) in the gefitinib group, the mean difference was 23% (95% CI: 10-37, p = 0.0011). Conclusions: Furmonertinib first-line treatment was found to have superior efficacy in CNS progression-free survival, CNS objective response rate, and CNS depth of response compared with gefitinib in patients with EGFR-mutated NSCLC with CNS metastases.

• 单位
  南通大学; 吉林大学; 1; 中国医学科学院; 哈尔滨医科大学; 中国医学科学院北京协和医院; 中国医科大学