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Updated: Jul 28, 2025

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第二阶段,开放性研究Encorafenib加Binimetinib在患有Encorafenib的患者中

Gregory J Riely¹, Egbert F Smit², Myung-Ju Ahn³

¹Memorial Sloan Kettering Cancer Center, New York, NY.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|June 4, 2023

概括

在患有BRAFV600E突变转移性非小细胞肺癌 (NSCLC) 的患者中,恩科拉费尼布加比尼米丁尼布显示出显著的临床益处. 这种组合疗法显示出有希望的响应率和可控的副作用,与其在黑色素瘤中的使用一致.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
遗传学是一个遗传学.

背景情况:

恩科拉费尼布 (BRAF抑制剂) 和比尼米蒂尼布 (MEK抑制剂) 的组合对BRAFV600E/K突变转移性黑色素瘤有效.
在转移性非小细胞肺癌 (NSCLC) 中也发现了BRAFV600E突变,这表明了潜在的治疗标.

研究的目的:

评估恩科拉费尼布加比尼米丁尼布在患有BRAFV600E突变转移性NSCLC的患者中的疗效和安全性.
评估客观反应率 (ORR),反应持续时间 (DOR),疾病控制率 (DCR),无进展生存率 (PFS) 和安全性.

主要方法:

一个正在进行的,开放的,单臂的II期研究.
98名患有BRAFV600E突变转移性NSCLC的患者接受了恩科拉费尼布 (每天450毫克) 以及比尼米提尼布 (每天两次45毫克).
主要终点:通过独立放射学审查 (IRR) 确认了ORR.

主要成果:

在以前未接受治疗的患者中,ORR为75%,而在之前接受治疗的患者中,ORR为46%.
在以前未接受治疗的患者中,PFS的中位数无法估计,而在之前接受治疗的患者中,PFS的中位数为9.3个月.
最常见的与治疗相关的不良事件包括恶心,腹和疲劳;剂量减少发生在24%的患者中.

结论:

在BRAFV600E突变转移性NSCLC的未接受治疗和先前接受治疗的患者中,Encorafenib和binimetinib显示出有意义的临床益处.
安全性概况与黑色素瘤患者观察到的安全性概况一致,支持其在NSCLC中的使用.

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