{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["15(3)"],"submitter":["Sheng Y"],"pubmed_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"],"journal":["CPT: pharmacometrics & systems pharmacology"],"pagination":["e70220"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12937503"],"repository":["biostudies-literature"],"pubmed_title":["Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data."],"pmcid":["PMC12937503"],"pubmed_authors":["Sheng Y","Shi Q","Xu F","Wang J","Wang K","Yue Z"],"additional_accession":[]},"is_claimable":false,"name":"Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data.","description":"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","dates":{"release":"2026-01-01T00:00:00Z","publication":"2026 Mar","modification":"2026-07-16T22:03:08.829Z","creation":"2026-07-11T03:09:35.635Z"},"accession":"S-EPMC12937503","cross_references":{"pubmed":["41744483"],"doi":["10.1002/psp4.70220"]}}