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突尼马提尼布 (HL-085) 加维穆拉费尼布治疗晚期BRAF V600突变固体瘤患者:一项开放式,单臂,多中心,I期研究

Yuankai Shi¹, Xiaohong Han², Qian Zhao²

¹Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, People's Republic of China. syuankai@cicams.ac.cn.

Experimental hematology & oncology

|June 12, 2024

概括

图内美提尼布加维穆拉费尼布在患有BRAF V600突变固体瘤的患者中显示出良好的安全性和有前途的抗瘤活性. 确定了非小细胞肺癌的II期推剂量.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

莱美丁 (HL-085) 是一种选择性的MEK抑制剂,在NRAS突变黑色素瘤中具有活性.
这一第一阶段研究研究了tunlametinib与vemurafenib结合在先进的BRAF V600突变固体瘤中.

研究的目的:

为了评估tunlametinib和vemurafenib的安全性和初步疗效.
为了确定组合治疗的推的II期剂量 (RP2D).

主要方法:

患有晚期BRAF V600突变固体瘤的患者接受了tunlametinib和vemurafenib.
该研究包括剂量升级和剂量扩展阶段.
安全性,RP2D和初步疗效是主要终点.

主要成果:

推的II期剂量 (RP2D) 是tunlametinib 9 mg加Vemurafenib 720 mg每天两次用于BRAF V600突变NSCLC.
在NSCLC患者中,客观反应率 (ORR) 为60.6%,中位数无进展生存期 (PFS) 为10.5个月,中位数反应持续时间 (DoR) 为11.3个月.
常见的3-4级与治疗相关的不良事件包括贫血和血中肌酸基酶升高;没有观察到药物相互作用.

结论:

图内美提尼布加维穆拉费尼布在BRAF V600突变固体瘤中表现出良好的安全性和有前途的抗瘤活性.
对于NSCLC患者来说,已确定的RP2D是tunlametinib 9 mg两次加上vemurafenib 720 mg两次.

关键词:

这就是BRAF.结肠直肠癌是一种癌症.这是一种MEK抑制剂.非小细胞肺癌是非小细胞肺癌.突尼西米尼 (Tunlametinib) 是一种药物.在Vemurafenib中使用.

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