ArticleDrug design, development and therapy2026
Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Venetoclax (VEN), a selective B-cell lymphoma 2 (BCL-2) inhibitor, is used in pediatric hematologic malignancies. Research on individualized VEN therapy in Chinese pediatric patients remains limited. This study aimed to develop a population pharmacokinetic (PPK) model in Chinese pediatric patients, identify covariates influencing pharmacokinetics, support personalized dosing, and explore exposure-efficacy relationships in pediatric acute myeloid leukemia (AML). Methods: PPK modeling was based on 225 plasma concentrations from 96 patients using nonlinear mixed-effects (NLME) modeling in Phoenix NLME software. A retrospective cohort of 52 AML patients receiving VEN with hypomethylating agents was analyzed, grouped as newly diagnosed or relapsed/refractory (R/R). Minimal residual disease (MRD) negativity was the primary endpoint. Mann-Whitney Results: A one-compartment model best described the pharmacokinetics of VEN. Body surface area (BSA) and the use of triazole drugs significantly influenced apparent clearance (CL/F), while total protein (TP) had a significant impact on apparent volume of distribution (V/F). The final model estimates were: ka = 0.15 h Conclusion: This study establishes the first real-world population pharmacokinetic model of venetoclax in Chinese pediatric patients and demonstrates a clinically meaningful exposure-response relationship. The positive association between VEN exposure and MRD negativity supports the use of therapeutic drug monitoring and PPK-guided dosing to optimize treatment in pediatric AML.
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