Alternative Dosing Regimens of Tislelizumab Using a Pharmacometrics Model-Based Approach.

ABSTRACT: Tislelizumab 200 mg once every 3 weeks (Q3W) is approved for the treatment of multiple cancers. We used a model-based approach to propose three alternative dosing regimens, 150 mg Q2W, 300 mg Q4W, and 400 mg Q6W, with the aims of providing flexible treatment regimens compatible with background chemotherapy and/or reducing infusion visits. A previously developed population pharmacokinetic model was used to simulate pharmacokinetic exposure of the alternative regimens. Regulatory guidance on alternative dosing was used to define pharmacokinetics-based criteria. Alternative doses were selected by simulation, exposure matching, and comparison to the reference regimen of 200 mg Q3W. Deviations from pharmacokinetics-based criteria were bridged using appropriate safety and efficacy references and

SUBMITTER: Rizwan A 

PROVIDER: S-EPMC12033006 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature