在局部晚期或转移性非小细胞肺癌中皮下施用tislelizumab:来自BGB-A317-103第一阶段研究的药理动力学和安全性结果
Minjiang Chen1, Iurie Bulat2, Marina Maglakelidze3
1Peking Union Medical College Hospital Beijing China.
概括
在非小细胞肺癌患者中,皮下施用tislelizumab显示出高生物可用性和一致的安全性和有效性. 这种皮下配方为静脉输送提供了一个有前途的替代方案.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 免疫治疗是一种免疫疗法.
背景情况:
- 蒂斯莱利祖马布是一种被批准用于静脉注射的抗PD-1单克隆抗体.
- 皮下药物输送可能在患者的方便性和医疗保健资源利用方面具有优势.
- 该研究评估了tislelizumab的新型皮下配方.
研究的目的:
- 评估皮下注射tislelizumab的药理动力学,安全性和疗效.
- 为了比较皮下注射与标准静脉注射途径.
- 为了评估tislelizumab加化疗在先前没有接受过治疗的高级或转移性非小细胞肺癌患者.
主要方法:
- 进行了一项开放的,多中心的I期研究 (BGB-A317-103).
- 第1部分涉及剂量和注射部位 (腹部/大腿) 的探索,交替使用皮下和静脉注射tislelizumab.
- 第二部分专注于在大腿部进行皮下注射tislelizumab的剂量扩大,这两种药物与化疗相结合.
主要成果:
- 与静脉注射相比,皮下用tislelizumab的最低度更高 (大腿:23.1微克/毫升,腹部:19.5微克/毫升).
- 估计的生物利用率为大腿注射85.6%,腹部注射72.4%.
- 初步的疗效显示总体响应率为44.4%,安全性概况一致,没有新的安全信号.
结论:
- 皮下注射的tislelizumab通过大腿和腹部注射具有很高的生物可用性.
- 安全性和有效性与之前对tislelizumab加化疗的研究一致.
- 进一步调查皮下注射tislelizumab对于非小细胞肺癌的治疗是有必要的.
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