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

ABSTRACT: 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 clinical trials, was externally validated using data from an extended-interval higher-dose regimen. Based on the validated popPK model, exposure simulations for high-weight European patients (80-150 kg) under various dosing scenarios were then compared to exposures in the pivotal Asian study. Result

SUBMITTER: Sheng Y 

PROVIDER: S-EPMC12937503 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature