University of Alabama at Birmingham, Birmingham, Alabama, USA.
West Cancer Center, Germantown, Tennessee, USA.
Clin Pharmacol Drug Dev. 2022 Sep;11(9):1099-1109. doi: 10.1002/cpdd.1133. Epub 2022 Jul 12.
The pharmacokinetics (PK) and safety of ofatumumab and bendamustine alone and in combination were evaluated in patients with treatment-naive or relapsed indolent B-cell non-Hodgkin lymphoma (iNHL). Patients were randomly assigned to ofatumumab and bendamustine or ofatumumab alone. Ofatumumab PK concentration profiles and parameters were similar, alone or in combination with bendamustine. A decrease of 14% in the maximum observed plasma concentration (C ) and 15% in the area under the plasma concentration-time curve (AUC) from time 0 to the last measurable concentration sampling time (AUC ) was observed for ofatumumab coadministered with bendamustine, which was not considered clinically relevant. Bendamustine PK concentration profiles and parameters were similar with or without ofatumumab. The most frequent treatment-related adverse event was infusion-related reaction in 53% in the combination arm and 47% in the ofatumumab arm. No relevant drug-drug interaction was observed between ofatumumab and bendamustine. Ofatumumab alone or in combination with bendamustine had a manageable safety profile.
奥法妥木单抗单药和联合苯达莫司汀治疗初治或复发惰性 B 细胞非霍奇金淋巴瘤（iNHL）患者的药代动力学（PK）和安全性。患者被随机分配至奥法妥木单抗联合苯达莫司汀或奥法妥木单抗单药组。奥法妥木单抗单独或联合苯达莫司汀的 PK 浓度曲线和参数相似。与奥法妥木单抗单药相比，奥法妥木单抗联合苯达莫司汀时，最大观测血浆浓度（C ）降低 14%，从 0 到最后一个可测量浓度采样时间的血浆浓度-时间曲线下面积（AUC ）降低 15%，这被认为无临床意义。有或无奥法妥木单抗时，苯达莫司汀的 PK 浓度曲线和参数相似。最常见的治疗相关不良事件是联合组 53%和奥法妥木单抗组 47%的输注相关反应。奥法妥木单抗和苯达莫司汀之间未观察到相关的药物相互作用。奥法妥木单抗单药或联合苯达莫司汀具有可管理的安全性。
