美国食品和药物管理局批准摘要:贝尔祖提凡用于患有晚期细胞癌的患者
Jaleh Fallah1, Brian L Heiss1, Hee-Koung Joeng1
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
概括
美国FDA批准了贝尔祖提凡用于先进的细胞癌 (RCC) 在先前治疗后. 贝尔祖提凡在对比试验中,与埃弗罗利蒙相比,在无进展生存期 (PFS) 中表现得更好.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 晚期细胞癌 (RCC) 构成了重大治疗挑战,尤其是在PD-1/PD-L1抑制剂和VEGF氨酸激酶抑制剂等标准疗法进展后.
- 贝尔祖提凡代表了一种新的治疗选择,针对涉及RCC病变的特定途径.
研究的目的:
- 评估贝尔祖提凡与埃弗罗利斯相比的疗效和安全性,用于治疗PD-1/PD-L1抑制剂和VEGF氨酸激酶抑制剂后进展的晚期RCC患者.
主要方法:
- LITESPARK-005试验是一个开放的,随机的,对头对头的研究,涉及746名晚期RCC患者.
- 患者被随机分配1:1接受贝尔祖提凡或埃弗罗利斯.
- 主要终点包括无进展生存率 (PFS) 和总生存率,通过盲目的独立中央审查进行评估.
主要成果:
- 贝尔祖提凡在PFS中表现出了统计学上显著的改善,与Everolimus相比 (HR = 0.75; P = 0.0008).
- 双臂之间的PFS中位数相似 (5.6个月),但Kaplan-Meier曲线显示出不成比例的危险.
- 贝尔祖提凡的客观反应率较高 (22%对3.6%),总体存活率有所改善,因不良事件而停止治疗的几率较低.
结论:
- 贝尔祖提凡是先进的RCC患者的有效治疗选择,这些患者在先前的PD-1/PD-L1抑制剂和VEGF氨酸激酶抑制剂治疗中进展.
- 在这种患者群体中,贝尔祖提凡提供了改善的PFS和相比Everolimus的良好的耐受性概况.
- 进一步的随访正在进行中,以充分成熟的整体生存数据.
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