在癌症治疗中使用抗体生物药物的免疫相关不良事件
Deepa Rajagopal1, Elliot MacLeod1, Diana Corogeanu1
1Immunotherapy, Biotherapeutics and Advanced Therapies Division, Science, Research, and Innovation Group, Medicines and Healthcare products Regulatory Agency (MHRA), Hertfordshire, UK.
再组合抗体是癌症治疗的重要方法,但与免疫相关的不良事件,如细胞因子释放综合征 (CRS),可能会限制它们的使用. 协调临床前安全性测试对于更好地临床翻译基于抗体的疗法至关重要.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 再组合抗体 (Abs) 是关键的癌症治疗药物,许多药物自Rituximab以来已获得批准.
- 基于抗体的疗法通过阻断途径,调节免疫力或输送药物来向癌症.
- 毒性,包括细胞因子释放综合征 (CRS),限制了这些疗法的临床使用.
研究的目的:
- 对基于抗体的新型癌症免疫疗法进行免疫相关不良事件 (irAEs) 的审查.
- 突出协调性临床前测试开发对安全性评估的重要性.
- 支持和完善基于抗体的生物治疗的临床翻译.
主要方法:
- 免疫相关不良事件 (irAEs) 的审查.
- 专注于针对免疫检查点 (IC) 的Abs,双特异的Abs (BsAbs) 和抗体药物联合体 (ADC).
- 讨论用于安全评估的临床前测试开发.
主要成果:
- 免疫相关不良事件 (irAEs) 是基于抗体的癌症治疗中的重大挑战.
- 细胞因子释放综合征 (CRS) 是一种主要的irAE,其特征是全身炎症.
- 特定类型的抗体疗法 (IC向Abs,BsAbs,ADCs) 与不同的irAE配置文件有关.
结论:
- 临床前试验的协调对于基于抗体的生物治疗药物的准确安全性评估至关重要.
- 改进的安全性评估将支持新型癌症免疫疗法的临床转化和疗效.
- 解决毒性概况对于扩大基于抗体的癌症治疗的好处至关重要.
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