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 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. Results indicated that while the 1200 mg Q3W dose provided adequate exposure for patients weighing up to 115 kg, those weighing 115-150 kg had lower exposures. To match the exposure-efficacy profile of the pivotal study, a 1500 mg Q3W dose was proposed for this higher-weight subgroup. Simulations from exposure-response (ER) models confirmed that the 1500 mg Q3W dose for high-weight patients would achieve comparable survival probabilities to the 1200 mg Q3W dose in Asian patients. The proposed regimen of 1500 mg Q3W for patients weighing over 115 kg ensures consistent therapeutic exposure, efficacy, and safety across diverse populations. The MIDD strategy for bridging dose regimens, substantiated by this study, enabled regulatory approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) without the need for additional dedicated clinical trials.