布罗利祖马布在患有高瘤突变负担的瘤患者中:来自向药剂和分析利用注册表研究的结果
Herbert L Duvivier1, Michael Rothe2, Pam K Mangat2
1Cancer Treatment Centers of America-Atlanta, Part of City of Hope, Newnan, GA.
概括
布罗利祖马布在晚期癌症患者中表现出抗瘤作用,这些患者具有高瘤突变负担 (HTMB). 这项针对性药物和分析利用注册表 (TAPUR) 试验中的研究在结肠直肠和其他晚期癌症队列中发现了疾病控制.
科学领域:
- 在瘤学瘤学.
- 基因组学就是基因组学.
- 临床试验 临床试验
背景情况:
- 针对性代理和分析利用注册表 (TAPUR) 研究是一个务实的篮子试验.
- 它评估了已批准的向药物在患有晚期癌症和可操作的基因组改变的患者中的抗瘤活性.
研究的目的:
- 报告高瘤突变负担 (HTMB) 和晚期结直肠癌 (CRC) 或其他用 pembrolizumab 治疗的晚期癌症患者队伍的数据.
- 评估 pembrolizumab 在这些患者群体中的抗瘤活性.
主要方法:
- 纳入了患有晚期癌症,可测量的瘤和没有标准治疗选择的患者.
- 主要终点是至少16周的疾病控制 (DC). 西蒙的两阶段设计被用于CRC队列.
- 低积累的组织学特异性队列被组合成一个组织学聚合 (HP) 队列进行分析.
主要成果:
- 77名HTMB患者 (28名CRC,49名其他晚期癌症) 接受了pembrolizumab.
- 在CRC队列中,DC率为31%,在HP队列中为45%,拒绝了15%DC的零假设.
- 对 CRC 的客观响应率为 11%,对 HP 的客观响应率为 26%. 在12名患者中发生了3级或严重的不良事件.
结论:
- 布罗利祖马布在先前接受治疗的患有晚期癌症和高瘤突变负担的患者中表现出抗瘤活性.
- 这些发现支持在特定的HTMB晚期癌症患者群体中使用 pembrolizumab.
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