ArticleCPT: pharmacometrics & systems pharmacology2017
Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Size Dynamics in Pembrolizumab-Treated Advanced Melanoma.
Article in CPT: pharmacometrics & systems pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Pooled it
- Dose dependence of treatment-related adverse events for immune checkpoint inhibitor therapies: a model-based meta-analysis.Oncoimmunology · 2020Pooled it
- Evaluation of dosing strategy for pembrolizumab for oncology indications.Journal for immunotherapy of cancer · 2017Pooled it
- Joint modeling of tumor dynamics and progression-free survival in advanced breast cancer: Leveraging data from amcenestrant early phase I-II trials.CPT: pharmacometrics & systems pharmacology · 2024Trial
- Comparative effectiveness of two alternative dosing strategies of pembrolizumab in metastatic non-small-cell lung cancer in a real-world setting.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Article
- Exposure-response relationship of sintilimab in advanced gastric cancer: insights from time-dependent pharmacokinetics and biomarker integration for precision immunotherapy.Frontiers in pharmacology · 2026Review
- Fc gamma receptor binding modulates IgG clearance in cancer cachexia.Frontiers in immunology · 2026Article
- Weight-Based Pembrolizumab Dosing at 4 mg/kg Every 6 Weeks Leads to Exposures Below Approved Doses with Unestablished Efficacy: A Pharmacokinetic Model-Based Simulation Analysis.Targeted oncology · 2025Article
- Pembrolizumab hybrid dosing is non-inferior to flat dosing in advanced non-small cell lung cancer: a real-world, retrospective bicenter cohort study.Journal for immunotherapy of cancer · 2025Article
- Stronger together: a cross-SIG perspective on improving drug development.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Utility and impact of quantitative pharmacology on dose selection and clinical development of immuno-oncology therapy.Cancer chemotherapy and pharmacology · 2024Review
- Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials.CPT: pharmacometrics & systems pharmacology · 2024Article
- Decoupling FcRn and tumor contributions to elevated immune checkpoint inhibitor clearance in cancer cachexia.Pharmacological research · 2024Article
- Modeling tumor size dynamics based on real-world electronic health records and image data in advanced melanoma patients receiving immunotherapy.CPT: pharmacometrics & systems pharmacology · 2023Article
- Comparison of sequential and joint nonlinear mixed effects modeling of tumor kinetics and survival following Durvalumab treatment in patients with metastatic urothelial carcinoma.Journal of pharmacokinetics and pharmacodynamics · 2023Article
- A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Semiautomated Pipeline to Quantify Tumor Evolution From Real-World Positron Emission Tomography/Computed Tomography Imaging.JCO clinical cancer informatics · 2023Article
- REFINE-Lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment.The Lancet. Oncology · 2023Review
- Virtual clinical trials: A tool for predicting patients who may benefit from treatment beyond progression with pembrolizumab in non-small cell lung cancer.CPT: pharmacometrics & systems pharmacology · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pembrolizumab is a potent immune-modulating antibody active in advanced melanoma, as demonstrated in the KEYNOTE-001, -002, and -006 studies. Longitudinal tumor size modeling was pursued to quantify exposure-response relationships for efficacy. A mixture model was first developed based on an initial dataset from KEYNOTE-001 to describe four patterns of tumor growth and shrinkage. For subsequent analyses, tumor size measurements were adequately described by a single consolidated model structure that captured continuous tumor size with a combination of growth and regression terms, as well as a fraction of tumor responsive to therapy. This revised model structure provided a framework to efficiently evaluate the impact of covariates and pembrolizumab exposure. Both models indicated that exposure to the drug was not a significant predictor of tumor size response, demonstrating that the dose range evaluated (2 and 10 mg/kg every 3 weeks) is likely near or at the plateau of maximal response.
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