Model‐Informed Dosing Regimen of Sugemalimab for European Patients With Non‐Small Cell Lung Cancer: Bridging From Asian Clinical Data

Model-informed drug development (MIDD) framework was employed to bridge sugemalimab dosing from an Asian population to European patients with non-small cell lung cancer. We evaluated whether a fixed dose of 1200 mg every 3 weeks (Q3W) provides adequate exposure for European patients and, if not, which weight threshold and alternative dose would restore pivotal-trial exposures and projected benefit. A population pharmacokinetic (popPK) model, developed from 1002 subjects (97.6% Asian) across six