伏美替尼(AST2818) 对比吉非替尼一线应用于EGFR突变非小细胞肺癌中的中枢神经系统疗效：来自 FURLONG 研究的结果

Introduction 引言

Furmonertinib (AST2818) is a pan-EGFR tyrosine kinase inhibitor with central nervous system (CNS) antitumor activity. We report the CNS efficacy of furmonertinib compared with gefitinib in untreated EGFR-sensitizing mutation-positive NSCLC from the FURLONG study.

伏美替尼 (AST2818) 是一种pan-EGFR酪氨酸激酶抑制剂 (TKI)，具有中枢神经系统 (CNS) 抗肿瘤活性。我们在 FURLONG 研究中报告了伏美替尼与吉非替尼在未经治的 EGFR 致敏突变阳性非小细胞肺癌 (NSCLC) 中的中枢神经系统疗效。

Methods 方法

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 examination. Patients with asymptomatic steady CNS metastases at baseline constituted this preplanned CNS subgroup analysis.

FURLONG 是一项在中华人民共和国 55 家医院进行的随机、双盲、3 期临床研究。患者1:1随机接受伏美替尼80mg Qd或吉非替尼250mg Qd治疗。在筛选时，所有患者都接受了头部影像学检查。基线时无症状的稳定 CNS 转移患者构成了该预先计划的 CNS 亚组分析。

Results 结果

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% confidence 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).

共有 358 名患者参加了 FURLONG 研究。在 133 名 (37%) 患有可评估或不可评估的中枢神经系统病灶的患者中，伏美替尼组的 CNS 无进展生存期 (PFS) 为 20.8 个月（95% 置信区间 [95%CI] 15.2, 25.3），吉非替尼组为9.8 个月（95%CI 7.2, 18.0）（风险比 0.40 [95%CI 0.23, 0.71]；p=0.0011）。在有可评估的CNS病灶的 60 名 (17%) 患者中，伏美替尼组的客观缓解率 (ORR) 为 91% (95%CI 72, 99) ，而吉非替尼组为65% (95%CI 48, 80) （优势比6.82 [95%CI 1.23, 37.67]；p=0.0277）。CNS反应深度的最小二乘平均差在伏美替尼组为62% (95% CI: 51-72)，在吉非替尼组为39% (95% CI: 30-47)，的最小二乘平均差为 23% (95%CI 10, 37; p=0.0011)，两组间的平均差为23% (95% CI: 10-37, p = 0.0011)。

Conclusions 结论

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.

与吉非替尼相比，伏美替尼一线治疗EGFR突变的中枢神经系统转移的NSCLC患者在其无病进展生存、客观缓解率以及反应深度方面显示出更优的疗效。

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