皮下或静脉注射尼沃卢马布用于细胞癌
L Albiges1, M T Bourlon2, M Chacón3
1Department of Oncology, Institut Gustave Roussy, Villejuif, France.
概括
在晚期细胞癌患者中,皮下尼沃卢马布证明与静脉注射无劣,提供了具有类似功效和安全性的新选择. 这种皮下配方可以改善患者体验和医疗保健效率.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 目前治疗晚期细胞癌的标准治疗包括静脉注射nivolumab.
- 需要改进的管理方法,以提高患者的便利性和医疗保健效率.
研究的目的:
- 评估皮下尼沃卢马布与静脉内尼沃卢马布相比,在患有晚期/转移性清晰细胞癌的患者中的非劣质性.
- 为了评估药理动力学参数和客观反应率 (ORR) 对于两个给药途径.
主要方法:
- 检查Mate 67T,一个第三阶段,开放标签,多中心,非劣等性试验,随机选择495名患者.
- 患者接受皮下尼沃卢马布 (1200毫克每4周) 或静脉内尼沃卢马布 (3毫克/公斤每2周).
- 非劣质性是通过人群药理动力学 (Cavgd28,Cminss) 和ORR来确定的.
主要成果:
- 与静脉注射尼沃卢马布相比,皮下尼沃卢马布的相对暴露为Cavgd28的2.098和Cminss的1.774.
- 皮下尼沃卢马布的客观反应率为24.2%,而静脉内尼沃卢马布的客观反应率为18.2%.
- 药物动力学终点和ORR都达到非劣势值,观察到类似的安全性概况.
结论:
- 在药理动力学和客观反应率方面,皮下尼沃卢马布与静脉内尼沃卢马布无差.
- 皮下注射的配方为晚期细胞癌治疗提供了可行的替代注射途径.
- 在皮下用尼沃卢马布给药时,没有发现新的安全问题.
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