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对抗FGFR/KLB双特异抗体 fazpilodemab的个性化剂量方法的基于模拟的评估

Kenta Yoshida¹, Victor Poon¹, Ajit Dash²

¹Clinical Pharmacology, Genentech Inc., South San Francisco, California, USA.

CPT: pharmacometrics & systems pharmacology

|February 12, 2024

概括

针对非酒精性脂肪肝炎的抗体fazpilodemab的个性化剂量优化了治疗效益. 基于不良事件的个性化剂量有效地管理风险,改善临床开发中的益处风险概况.

科学领域:

药理学和药物开发领域
临床试验设计临床试验设计
生物技术是生物技术.

背景情况:

个性化剂量对于优化药物效益:风险概况至关重要,特别是在治疗窗口狭窄的药物中.
这种策略在药物开发中至关重要,但需要在临床试验期间进行彻底评估.
作为一种双特异性抗体,法兹皮洛德玛布 (Fazpilodemab,BFKB8488A) 正在开发用于非酒精性脂肪肝炎.

研究的目的:

为了描述fazpilodemab的暴露-反应关系.
为了指导二期研究的剂量选择.
评估个性化剂量策略,以优化治疗效益.

主要方法:

静态暴露-反应分析.
使用离散时间马尔科夫模型进行纵向不良事件分析.
临床试验模拟以评估目标药动力学反应和胃肠道不良事件 (GIAE) 频率.

主要成果:

对于药理动力学生物标志物和GIAE (恶心,吐) 确定了明确的暴露-反应关系.
临床试验模拟为II期剂量选择提供了信息.
动态模拟表明,基于不良事件的个性化剂量最有效地优化了益处风险概况.

结论:

个性化剂量,特别是基于AE的策略,对于优化益处风险概况是有效的.
提出的框架可以量化个性化剂量对治疗窗口狭窄的药物的好处.
这种方法支持在临床开发中明智选择剂量.

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