Ann Oncol:癌症患者,纳武单抗每4周480 mg给药方案靠谱吗?

2019-01-10 吴星 环球医学

每4周(Q4W)480?mg的纳武单抗单药单一剂量给药方案,已获包括美国、加拿大和欧盟在内的许多市场的批准,作为多种适应症的替代给药方案。该Q4W方案的批准基于群体药代动力学(PK)分析,建立的平坦暴露-反应关系和临床安全性。2018年11月,发表在《Ann Oncol.》的一项研究调查了癌症患者纳武单抗暴露与480?mg Q4W单一剂量方案的临床安全性。

每4周(Q4W)480?mg的纳武单抗单药单一剂量给药方案,已获包括美国、加拿大和欧盟在内的许多市场的批准,作为多种适应症的替代给药方案。该Q4W方案的批准基于群体药代动力学(PK)分析,建立的平坦暴露-反应关系和临床安全性。2018年11月,发表在《Ann Oncol.》的一项研究调查了癌症患者纳武单抗暴露与480?mg Q4W单一剂量方案的临床安全性。

目的:此项研究的目的是使用模型和模拟,比较480?mg Q4W与3?mg/kg每2周(Q2W)和240?mg Q2W的PK暴露,并评价Q4W方案的临床安全性。

受试者和方法:模拟3817例不同肿瘤类型患者480?mg Q4W方案的纳武单抗PK暴露,并与3?mg/kg Q2W和240?mg Q2W方案进行比较。通过分析在4项III期临床试验中从纳武单抗3?mg/kg Q2W转换为480?mg Q4W的61例患者的临床数据,评价Q4W方案的安全性。

结果:与3?mg/kg Q2W相比,纳武单抗480?mg Q4W产生类似的平均时间浓度,谷浓度大约低16%,稳态峰浓度高45%。480?mg Q4W方案的峰浓度显著低于此前显示出耐受性和安全性较好的10?mg/kg Q2W方案。从3?mg/kg Q2W转换到480?mg Q4W方案的患者,14.8%报告了治疗相关不良事件(TRAEs),1.6%的患者报告的TRAEs等级在3~4级。这些患者的汇总安全数据与使用3?mg/kg Q2W方案的患者一致,没有鉴定出新的安全信号。

结论:对于不同肿瘤类型,纳武单抗480?mg Q4W方案的平均时间稳态暴露和安全性与3?mg/kg Q2W方案一致。纳武单抗480?mg Q4W方案代表一个新的给药方案选择,除了240?mg Q2W外,纳武单抗480?mg Q4W方案为患者治疗提供了便利和弹性。

原始出处:

Long GV, Tykodi SS, Schneider JG, et.al. Assessment of nivolumab exposure and clinical safety of 480?mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

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