在ROS1+非小细胞肺癌中使用taletrectinib: TRUST
Maurice Pérol1, Wei Li2, Nathan A Pennell3
1Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.
概括
塔莱特雷克提尼布在ROS1+非小细胞肺癌中显示出高疗效,显示出持久的反应和中枢神经系统活性. 在TKI-naïve和预先治疗的患者中,治疗耐受性良好,安全性概况良好.
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:
- 具有ROS1变化的非小细胞肺癌 (NSCLC) 是一个独特的分子亚型.
- 氨酸激酶抑制剂 (TKI) 向ROS1已经改善了结果,但耐药性和中枢神经系统转移仍然是挑战.
研究的目的:
- 评估taletrectinib的综合疗效和安全性,这是下一代ROS1TKI,在ROS1+NSCLC患者中.
- 评估taletrectinib在TKI-naive和TKI-pretreated人群中的性能,包括其中枢神经系统 (CNS) 活性.
主要方法:
- 进行了第二阶段,单臂,开放标签,多中心试验 (TRUST-I和TRUST-II).
- 有效性结果,包括确认的客观反应率 (cORR) 和内 (IC) -cORR,被组合起来.
- 从所有每天服用600毫克taletrectinib治疗的患者中收集了安全数据.
主要成果:
- 在TKI-naïve患者 (n=160) 中,cORR为88.8%,IC-cORR为76.5%.
- 在TKI预治疗患者 (n=113) 中,cORR为55.8%,IC-cORR为65.6%.
- 无进展生存期 (PFS) 的中位数为TKI-naïve患者的45.6个月,TKI预治疗患者的9.7个月. 大多数治疗出现的不良事件是低度的胃肠道事件和升高的肝酶.
结论:
- 塔莱特雷克提尼布在ROS1+NSCLC中表现出显著的疗效,包括持久的反应和强大的中枢神经系统活性.
- 该药物表现出良好的安全性,严重不良事件的发生率低,神经毒性很少出现.
- 塔莱特雷克提尼布对ROS1+NSCLC的TCI-naïve和TCI-pretreated患者来说是一个有前途的治疗选择.
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