Weight-Based Pembrolizumab Dosing at 4 mg/kg Every 6 Weeks Leads to Exposures Below Approved Doses with Unestablished Efficacy: A Pharmacokinetic Model-Based Simulation Analysis.

ABSTRACT:

Background

Pembrolizumab is approved globally at a dose of 200 mg every 3 weeks (Q3W) or 400 mg every 6 weeks (Q6W) intravenously (IV). These dosing recommendations are based on established regimens that have demonstrated efficacy in clinical trials. Recently, pembrolizumab dosing at 4 mg/kg Q6W has been suggested as an alternative regimen; however, efficacy has not been evaluated in any prospective, controlled clinical trial.

Objective

The objective was to describe the pharmacokinetic model-based analyses of pembrolizumab 4 mg/kg Q6W IV compared with approved dosing regimens.

Patients and methods

The pharmacokinetic profiles for pembrolizumab were simulated for 4 mg/kg Q6W, 400 mg Q6W, 200 mg Q3W, and 2 mg/kg Q3W IV in 3607 participants from clinical trials of pembro

SUBMITTER: Lala M 

PROVIDER: S-EPMC12669309 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature