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在EGFR-TKI-耐药,EGFR-突变的高级NSCLC中,Sacituzumab Tirumotecan
Wenfeng Fang1, Lin Wu2, Xiangjiao Meng3
1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China.
The New England journal of medicine
|October 22, 2025
概括
萨西图祖马布提鲁莫特干 (sac-TMT) 显著改善了EGFR突变非小细胞肺癌 (NSCLC) 患者在先前治疗后进展的无进展和整体存活率. 在这种先进的NSCLC群体中,Sac-TMT为化疗提供了一种优越的替代方案.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 药理学 药理学是指药理学的学科.
背景情况:
- 萨西图祖马布提鲁莫特干 (sac-TMT) 是一种抗体-药物结合物,向热细胞细胞表面抗原2.
- 它在EGFR突变非小细胞肺癌 (NSCLC) 患者的EGFR TKI和化疗后的生存益处已经得到证明.
- 这项研究侧重于患有EGFR突变的晚期或转移性非状NSCLC的患者,这些患者在标准治疗后进展.
研究的目的:
- 为了比较sacituzumab tirumotecan (sac-TMT) 单一疗法的疗效与pemetrexed加基化疗的疗效.
- 评估无进展生存率 (PFS) 作为主要终点和整体生存率 (OS) 作为关键次要终点.
- 报告从第三阶段试验中PFS的最终分析和OS的中间分析.
主要方法:
- 一项3期随机对照试验,涉及376名EGFR突变的晚期或转移性非状性NSCLC患者.
- 患者被分配1:1接受sac-TMT单疗法或pemetrexed加基化疗.
- 无进展生存率通过盲目独立评价进行评估;整体生存率是分层测试的二次终点.
主要成果:
- 与化疗 (4.3个月) 相比,sac-TMT (8.3个月) 的中位数无进展生存时间显着更长 (HR,0.49;P<0.0001).
- 整体存活率也得到了显著的改善,用sac-TMT (HR,0.60;P=0.001),与18个月的OS率为65.8%对比48.0%.
- 3级或更高的与治疗相关的不良事件是可比的 (58.0%的sac-TMT vs. 53.8%的化疗),中性粒细胞数量的减少在sac-TMT手臂中最常见.
结论:
- 与基化疗相比,sacituzumab tirumotecan (sac-TMT) 在EGFR突变晚期NSCLC患者的EGFR TKI后治疗中显示出更高的无进展和整体存活率.
- 在这种患者群体中,Sac-TMT代表了显著的治疗进步.
- 这项研究由四川凯隆-生物技术生物制药公司 (临床试验.gov号:NCT05870319) 资助.
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