Publication: CPT: Pharmacometrics & Systems Pharmacology (PSP)
Abstract
This publication describes a simultaneous population pharmacokinetic/pharmacodynamic (PK/PD) model developed to characterize the dynamic relationships between belantamab mafodotin, soluble B-cell maturation antigen (sBCMA), and serum M-protein in patients with relapsed/refractory multiple myeloma. Using data from 510 patients across four DREAMM clinical trials, the integrated model captured the relationships between drug exposure, disease burden, and longitudinal biomarkers. Simulations demonstrated that higher belantamab mafodotin doses were associated with greater reductions in M-protein and free sBCMA. The findings demonstrate how simultaneous PK/PD modeling can deepen understanding of drug–disease interactions and support dose and regimen evaluation in oncology drug development.
Authors: Josh Kaullen and Adekemi Taylor (Certara), John D. Clements, Inmaculada C. Sorribes, Christine Neumar, Mun Sang Yue, Xi Chen, Herbert Struemper, Geraldine Ferron-Brady
Published: September 29, 2026
Advance oncology drug development with pharmacometrics
Use population PK/PD, exposure-response modeling, and simulation to better understand drug–disease relationships, evaluate dosing strategies, and generate quantitative evidence to support critical development and regulatory decisions.
