ReviewClinical pharmacology and therapeutics2020
Characterizing Exposure-Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects.
Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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
58 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Skipping a pillar does not make for strong foundations: Pharmacokinetic-pharmacodynamic reasoning behind the shape of dose-response relationships in oncology.CPT: pharmacometrics & systems pharmacology · 2023Pooled it
- Exposure-Response Relationship of Dostarlimab in Primary Advanced/Recurrent Endometrial Cancer: Results From Interim Analysis 2 of Part 1 of the RUBY Trial.Clinical pharmacology in drug development · 2026Trial
- Exposure-response analyses for belantamab mafodotin in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma from DREAMM-6 Arm B and DREAMM-7.British journal of cancer · 2026Trial
- Population pharmacokinetics and exposure-response analysis of durvalumab in patients with resectable stage II to IIIB (N2) NSCLC in the phase III AEGEAN study.British journal of clinical pharmacology · 2026Trial
- Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Comprehensive Exposure-Response Analysis of the DREAMM-8 Study.Targeted oncology · 2025Trial
- Population Pharmacokinetics and Exposure-Response of Subcutaneous Atezolizumab in Patients With Non-Small Cell Lung Cancer.CPT: pharmacometrics & systems pharmacology · 2025Trial
- Population pharmacokinetics and exposure-response relationships of dostarlimab in primary advanced or recurrent endometrial cancer in part 1 of RUBY.British journal of clinical pharmacology · 2025Trial
- Longitudinal modeling of efficacy response in patients with lupus nephritis receiving belimumab.Journal of pharmacokinetics and pharmacodynamics · 2024Trial
- Population pharmacokinetics and exposure-response analyses of polatuzumab vedotin in patients with previously untreated DLBCL from the POLARIX study.CPT: pharmacometrics & systems pharmacology · 2024Trial
- Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Trial
- Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer.CPT: pharmacometrics & systems pharmacology · 2022Trial
- Exposure-response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy.British journal of clinical pharmacology · 2022Trial
- Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B-Cell Hematological Malignancies.Clinical pharmacology and therapeutics · 2021Trial
- Time-Dependent Bias and Prognostic Confounding in Exposure-Response Analysis of Targeted Therapies: Lessons from Sunitinib in Metastatic Renal Cancer.Clinical pharmacology and therapeutics · 2026Article
- Exposure-Response Relationships of Antibody Drug Conjugates in Solid Tumours.Clinical pharmacokinetics · 2026Review
- The CetuxIMAX study: a population pharmacokinetic approach to modelling the pharmacokinetics and pharmacodynamics relationships of Cetuximab in patients with head and neck cancer.Cancer chemotherapy and pharmacology · 2026Article
- Applications of Pharmacometrics in Antibody-Drug Conjugate Development.Pharmaceutics · 2026Review
- Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data.CPT: pharmacometrics & systems pharmacology · 2026Article
- Causal Directed Acyclic Graphs to Mitigate Confounding Bias in Exposure-Response Analyses.CPT: pharmacometrics & systems pharmacology · 2026Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent data from immuno-oncology clinical studies have shown the exposure-response (E-R) relationship for therapeutic monoclonal antibodies (mAbs) was often confounded by various factors due to the complex interplay of patient characteristics, disease, drug exposure, clearance, and treatment response and presented challenges in characterization and interpretation of E-R analysis. To tackle the challenges, exposure relationships for therapeutic mAbs in immuno-oncology and oncology are reviewed, and a general framework for an integrative understanding of E-R relationship is proposed. In this framework, baseline factors, drug exposure, and treatment response are envisioned to form an interconnected triangle, driving the E-R relationship and underlying three components that compose the apparent relationship: exposure-driven E-R, baseline-driven E-R, and response-driven E-R. Various strategies in data analysis and study design to decouple those components and mitigate the confounding effect are reviewed for their merits and limitations, and a potential roadmap for selection of these strategies is proposed. Specifically, exposure metrics based on a single-dose pharmacokinetic model can be used to mitigate response-driven E-R, while multivariable analysis and/or case control analysis of data obtained from multiple dose levels in a randomized study may be used to account for the baseline-driven E-R. In this context, the importance of collecting data from multiple dose levels, the role of prognostic factors and predictive factors, the potential utility of clearance at baseline and its change over time, and future directions are discussed.
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