Evaluation of dosing strategy for pembrolizumab for oncology indications.

ABSTRACT:

Background

Traditionally, most monoclonal antibodies (mAbs) have been dosed based on body weight because of perceived contribution of body size in pharmacokinetic variability. The same approach was used in the initial pembrolizumab studies; however, following availability of PK data, the need for weight-based dosing for pembrolizumab was reassessed.

Methods

A previously established population PK (popPK) model as well as exposure-response results from patients with advanced melanoma or non-small cell lung cancer (NSCLC) were used to evaluate the potential application of a fixed dosing regimen with the aim of maintaining pembrolizumab exposures within the range demonstrated to provide near maximal efficacy and acceptable safety. Individual PK exposures for the selected fixed d

SUBMITTER: Freshwater T 

PROVIDER: S-EPMC5433037 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature