biostudies-literatureUnknown15(3)Sheng YModel-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. ResultCPT: pharmacometrics & systems pharmacologye70220https://www.ebi.ac.uk/biostudies/studies/S-EPMC12937503biostudies-literatureModel-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data.PMC12937503Sheng YShi QXu FWang JWang KYue ZfalseModel-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 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. Result2026-01-01T00:00:00Z2026 Mar2026-07-16T22:03:08.829Z2026-07-11T03:09:35.635ZS-EPMC129375034174448310.1002/psp4.70220