Model-Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation.

ABSTRACT: A subcutaneous formulation of nivolumab was evaluated in the phase III study CheckMate 67T (NCT04810078). The co-primary pharmacokinetic exposure endpoints, time-averaged serum concentration over the first 28 days (C_avgd28), and steady-state trough concentration (C_minss) were determined through population pharmacokinetic analysis as compared to conventional non-compartmental analysis (NCA). We proposed a model-based approach to determine subcutaneous and intravenous nivolumab exposures in CheckMate 67T, leveraging extensive prior pharmacokinetic data across various tumor types. The robustness of this model-informed drug development (MIDD) approach was assessed via clinical trial simulations. Concentration-time profiles in randomly sampled patients with renal cell carc

SUBMITTER: Zhao Y 

PROVIDER: S-EPMC12706396 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature