奥西默蒂尼布与或没有savolitinib作为MET异常,EGFR突变NSCLC的第一线治疗:随机二期试验 (FLOWERS)
Anna Li1, Wei-Neng Feng2, Juan Li3
1Division 1 of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.
Nature communications
|January 13, 2026
概括
与osimertinib单独相比,osimertinib和savolitinib的组合在治疗EGFR突变和MET异常的晚期非小细胞肺癌 (NSCLC) 中表现出更高的疗效. 这种组合疗法显示出更高的客观反应率和可管理的安全性.
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:
- 非小细胞肺癌 (NSCLC) 仍然是全球癌症相关死亡的主要原因.
- 皮表皮生长因子受体 (EGFR) 突变是NSCLC的常见驱动因素,MET异常可以赋予针对性治疗的耐药性.
- 新的MET异常,包括放大或过度表达,在NSCLC治疗中构成了特殊的挑战.
研究的目的:
- 评估奥西默提尼布与萨沃利提尼布联合治疗的疗效和安全性,用于先前未接受过治疗的患有晚期NSCLC的患者.
- 为了比较与EGFR突变和de novo MET异常患者的异辛单一治疗相比,组合治疗的结果.
- 确定确认的客观响应率 (ORR) 作为这一第二阶段研究的主要终点.
主要方法:
- 进行了一项随机的,多中心的,开放的,二期研究 (NCT05163249).
- 以前没有接受过治疗的患有晚期NSCLC,EGFR突变和de novoMET异常的患者被随机分为两个队列.
- 第一个队伍接受了奥西默蒂尼布单一治疗 (每天80毫克),而第二队伍接受了组合治疗 (每天80毫克的奥西默蒂尼布+每天两次300毫克的萨沃利提尼布).
主要成果:
- 确认的客观响应率 (ORR) 在组合手臂 (90.5%) 与奥西默蒂尼布单一治疗 (60.9%) 相比显著更高.
- 综合疗法 (95.2%) 与单一疗法 (87%) 的疾病控制率也更高.
- 3级或更高的与治疗相关的不良事件在组合手臂 (57.1%) 比单一治疗手臂 (8.7%) 更频繁,但被认为是可以控制的.
结论:
- 奥西默提尼布和萨沃利提尼布的组合在患有EGFR突变和de novoMET异常的晚期NSCLC患者中显示出有前途的抗瘤活性.
- 这种组合疗法在客观响应率上有显著的改善,与单独治疗 osimertinib 相比.
- 虽然组合疗法与不良事件增加有关,但其安全性概况似乎是可控的,需要进一步调查.
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