Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin^®) in patients with HER2-positive metastatic breast cancer.

ABSTRACT:

Purpose

PF-05280014 is a biosimilar to trastuzumab (Herceptin^®). Following demonstration of pharmacokinetic (PK) similarity in healthy volunteers, a comparative clinical study in patients with HER2-positive metastatic breast cancer (mBC) compared the efficacy, safety and immunogenicity of PF-05280014 and trastuzumab sourced from the EU (trastuzumab-EU), both with paclitaxel.

Methods

Population PK of PF-05280014 and trastuzumab-EU was evaluated.

Results

Overall, 702 patients were treated: PF-05280014 (n = 349) and trastuzumab-EU (n = 353). Peak-and-trough serum drug concentration samples were collected (selected doses) following repeated intravenous administration of PF-05280014 or trastuzumab-EU. Population PK analysis was performed with drug concentration-

SUBMITTER: Chen X 

PROVIDER: S-EPMC6586910 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature