SynthesisJournal for immunotherapy of cancer2017
Evaluation of dosing strategy for pembrolizumab for oncology indications.
Synthesis in Journal for immunotherapy of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 128 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
128 citing papers in PubMed, 3 syntheses or guidelines pooled it, 247 citations in OpenAlex.
- Modulation of tumor-associated lymphangiogenesis by combination immunotherapy approaches in triple-negative breast cancer: a systematic review.Frontiers in immunology · 2026Pooled it
- Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.Breast cancer research : BCR · 2024Pooled it
- Population pharmacokinetic models of anti-PD-1 mAbs in patients with multiple tumor types: A systematic review.Frontiers in immunology · 2022Pooled it
- Evaluation of Innate Immune System, Body Habitus, and Sex on the Pharmacokinetics and Pharmacodynamics of Anetumab Ravtansine in Patients With Cancer.Clinical and translational science · 2025Trial
- Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation.Journal of clinical pharmacology · 2022Trial
- Pharmacokinetic and pharmacodynamic effects of ravulizumab and eculizumab on complement component 5 in adults with paroxysmal nocturnal haemoglobinuria: results of two phase 3 randomised, multicentre studies.British journal of haematology · 2020Trial
- KEYNOTE-032: A Randomized Phase I Study of Pembrolizumab in Chinese Patients with Advanced Non-Small Cell Lung Cancer.The oncologist · 2020Trial
- Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study.Lung cancer (Amsterdam, Netherlands) · 2018Trial
- From Reflection to Implementation: Tailored Clinical Development of a Pembrolizumab Biosimilar Candidate.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Translational modelling challenges receptor‑occupancy‑based dosing of PD‑1 inhibitors like pembrolizumab.British journal of cancer · 2026Article
- Population Pharmacokinetics and Exposure-Response of Sasanlimab, a Checkpoint Inhibitor, in Patients with Non-Muscle Invasive Bladder Cancer and Other Solid Tumors.Journal of clinical pharmacology · 2026Article
- Population pharmacokinetics for the CTLA-4 modulator gotistobart in patients with advanced solid tumors.Journal of clinical pharmacology · 2026Article
- Dosing challenges for chemotherapy and immunotherapy in congenital achondroplasia: a case report and literature review.Cancer chemotherapy and pharmacology · 2026Review
- Advances in Immunotherapy for Intrahepatic Cholangiocarcinoma.International journal of molecular sciences · 2026Review
- Systemic Inflammation as a Modulator of FcRn-dependent IgG Pharmacokinetics: Implications for Broadly Neutralising Antibody Efficacy in HIV Prevention.Current HIV/AIDS reports · 2026Review
- Dose optimization of immune checkpoint inhibitors for gastrointestinal malignancies.ESMO gastrointestinal oncology · 2026Review
- De-risking Biopharma Asset Acquisition: Towards a Quantitative Framework for Strategic Decision-making.The AAPS journal · 2026Review
- Clinical Safety of Extended Interval Dosing of Nivolumab in Patients with Melanoma.Clinical pharmacology and therapeutics · 2026Article
- Obesity and Cancer: From Systemic Metabolic Reprogramming to Immunotherapy Paradox.Metabolites · 2026Review
68 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTraditionally, most monoclonal antibodies (mAbs) have been dosed based on body weight because of perceived contribution of body size in pharmacokinetic variability. The same approach was used in the initial pembrolizumab studies; however, following availability of PK data, the need for weight-based dosing for pembrolizumab was reassessed.
methodsA previously established population PK (popPK) model as well as exposure-response results from patients with advanced melanoma or non-small cell lung cancer (NSCLC) were used to evaluate the potential application of a fixed dosing regimen with the aim of maintaining pembrolizumab exposures within the range demonstrated to provide near maximal efficacy and acceptable safety. Individual PK exposures for the selected fixed dosing regimen from recently completed trials with head and neck cancer, NSCLC, microsatellite instability high (MSI-H) in colorectal cancer (CRC) and urothelial cancer were used to confirm acceptability. To determine whether fixed dosing would maintain exposures within the range of clinical experience, the individual AUC distributions with fixed dosing were compared with the range of exposures from the pembrolizumab doses that were evaluated in early studies (2 mg/kg Q3W, 10 mg/kg Q3W/Q2W).
resultsBody-weight dependence of clearance was characterized by a power relationship with an exponent of 0.578, a value consistent with fixed- and weight-based dosing providing similar control of PK variability. A fixed dose of 200 mg Q3W was investigated in trials based on predicted exposures maintained within the established exposure range in all patients. Mean (% CV, n) AUC
conclusionsDoses of 200 mg and 2 mg/kg provide similar exposure distributions with no advantage to either dosing approach with respect to controlling PK variability. These findings suggest that weight-based and fixed-dose regimens are appropriate for pembrolizumab.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.