INDUCE-3:在患有复发性/转移性头支状细胞癌的患者中,对一线费拉迪利马布加布罗利祖马布进行随机的II/III期研究
Danny Rischin1, Aaron R Hansen2, Ezra E W Cohen3
1Peter MacCallum Cancer Centre Melbourne, Victoria Australia.
概括
INDUCE-3试验发现,将费拉迪利马布添加到布罗利祖马布并没有改善头部和部状细胞癌患者的结果. 这种组合治疗与单独使用布罗利祖马布相比没有显著的益处.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 费拉迪利马布是一种T细胞共刺激受体激动剂.
- 之前的I期数据表明,在头部和部状细胞癌 (HNSCC) 中具有潜在的活性.
研究的目的:
- 评估费拉迪利马布加布罗利祖马布与安慰剂加布罗利祖马布在一线HNSCC中的疗效和安全性.
- 评估总生存率 (OS) 和无进展生存率 (PFS) 作为主要终点.
主要方法:
- INDUCE-3是一个随机的,双盲的II/III期研究.
- 一线PD-L1阳性复发性/转移性HNSCC患者被随机分组为1:1.
- 治疗涉及多达35个周期,大约2年.
主要成果:
- 由于基于对140名患者的临时分析,该研究因徒劳而提前停止.
- 费拉迪利马布加上潘布罗利祖马布没有表现出优越性,调整后的HR为OS的1.51,PFS的1.40.
- 平均生存期为44.1周 (费拉迪利马布手臂) 与未达到 (安慰剂手臂);平均PFS分别为10.1周和16.0周.
结论:
- 费拉迪利马布和潘布罗利祖马布的联合治疗不支持一线HNSCC治疗.
- 该研究未能显示相对于安慰剂加 pembrolizumab 的益处.
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