PD-1 Inhibitor · Humanised IgG4κ mAb · Anti-PD-1

Pembrolizumab Keytruda®

A humanised IgG4κ monoclonal antibody targeting the programmed death-1 (PD-1) checkpoint receptor on T cells. By blocking PD-1 interactions with PD-L1 and PD-L2, pembrolizumab restores anti-tumour T cell activity across a broad range of oncology indications. Approved for numerous tumour types including melanoma, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, MSI-H/dMMR solid tumours and others. The SHIKARI® pembrolizumab portfolio provides free drug quantification, qualitative and quantitative ADA detection and the T-CAP NAb Assay™ for neutralising antibody characterisation.

SHIKARI® Kits

Tests per kit

Analytical Domains

RUO

Research Use Only

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Tyre tracks in snow, the official Pembrolizumab Trace & Catch visual — TRACE & CATCH · PEMBROLIZUMAB

Scientific Background

Why Pembrolizumab is relevant to biological-drug monitoring research

Pembrolizumab has clinically important target biology, indication-specific dosing and measurable systemic exposure, making drug concentration and immunogenicity relevant research variables. Scientific source ↗ · EMA source ↗

Mechanism

Molecular Target & Structure

Pembrolizumab is a humanised IgG4κ monoclonal antibody that binds PD-1 on activated T cells and blocks interaction with PD-L1 and PD-L2. Source ↗

Indications

Approved Indications

EMA-authorised uses span numerous cancers including melanoma, non-small cell lung cancer, head-and-neck cancer, classical Hodgkin lymphoma, MSI-H/dMMR tumours, renal-cell carcinoma, endometrial cancer, triple-negative breast cancer and gastrointestinal malignancies, with biomarker and regimen requirements varying by indication. EMA source ↗

Published Evidence

Exposure–Response Context

Regulatory analyses found a relatively flat exposure–response relationship across the studied dose range, so a universal therapeutic trough threshold should not be presented.

Studied dose range2–10 mg/kg ↗

Therapeutic trough thresholdNot established ↗

Research-associated ranges, not universal treatment cut-offs. Values vary by endpoint, timing, assay method and population. This page is for RUO product information and does not provide clinical guidance.

SHIKARI® Kit Portfolio

Four kits. Drug levels, qualitative ADA, quantitative ADA and neutralising antibodies.

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Drug Levels Kit

SHIKARI® Q-PEM

Quantitative Determination of Pembrolizumab (Keytruda®) ELISA

REF: PEM-FD-KEY

Sandwich ELISA for the quantitative measurement of free pembrolizumab in serum and plasma. Calibrated against certified reference standards. 140-minute total assay time. Suitable for pharmacokinetic research across all pembrolizumab-approved oncology indications and dosing regimens (200 mg every 3 weeks and 400 mg every 6 weeks).

Representative Standard Curve

96Tests/kit

2–8°CStorage

10–30°CShipment

Sandwich ELISASerum / Plasma

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Full technical datasheet on matriksbiotek.com ↗

Qualitative ADA Kit

SHIKARI® S-ATP

Qualitative Determination of Antibodies to Pembrolizumab ELISA

REF: PEM-QLS-KEY

Bridging ELISA for the qualitative detection of anti-pembrolizumab antibodies (ADA) in serum and plasma. Validated positive and negative cut-off controls included. 140-minute total assay time. Suitable for immunogenicity screening across all pembrolizumab oncology indications and treatment lines.

96Tests/kit

2–8°CStorage

10–30°CShipment

Bridging ELISASerum / Plasma

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Full technical datasheet on matriksbiotek.com ↗

Quantitative ADA Kit

SHIKARI® S-ATP

Quantitative Determination of Antibodies to Pembrolizumab ELISA

REF: PEM-QNS-KEY

Calibrated bridging ELISA for the quantitative determination of anti-pembrolizumab ADA titre in serum and plasma. Confirmation reagent included for drug interference assessment. 140-minute total assay time. Suitable for longitudinal ADA titre monitoring and kinetic profiling across pembrolizumab oncology indications.

Representative Standard Curve

96Tests/kit

2–8°CStorage

10–30°CShipment

Bridging ELISACalibrated

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Full technical datasheet on matriksbiotek.com ↗

Neutralising Ab Kit

SHIKARI® T-CAP NAb Assay™

Target Capture Neutralising Antibodies Immunoassay — Pembrolizumab

REF: PEM-TCAP-NAb-KEY

Target capture-based immunoassay for the detection of neutralising anti-pembrolizumab antibodies (NAb) in serum and plasma. Uses PD-1 target capture to identify only ADA that competitively block pembrolizumab's PD-1 binding site — functionally distinguishing neutralising from non-neutralising antibodies. Positive, negative, cut-off and non-neutralising antibody controls included. 140-minute total assay time.

96Tests/kit

2–8°CStorage

10–30°CShipment

Target CaptureNeutralising ADA

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Full technical datasheet on matriksbiotek.com ↗

Technical Reference

Kit Specifications at a Glance

Kit Name	Catalog Code	Type	Analyte	Format	Tests	Storage
SHIKARI® Q-PEM	PEM-FD-KEY	Drug Levels	Free pembrolizumab concentration	Sandwich ELISA	96	2–8°C
SHIKARI® S-ATP (Qualitative)	PEM-QLS-KEY	Qualitative ADA	Qualitative anti-pembrolizumab ADA	Bridging ELISA	96	2–8°C
SHIKARI® S-ATP (Quantitative)	PEM-QNS-KEY	Quantitative ADA	Anti-pembrolizumab ADA titre	Bridging ELISA (calibrated)	96	2–8°C
SHIKARI® T-CAP NAb Assay™	PEM-TCAP-NAb-KEY	Neutralising ADA	Neutralising anti-pembrolizumab antibodies	Target Capture Immunoassay	96	2–8°C

Kit Selection Guide

Which kit fits your research question?

Four assay formats address the full spectrum of pembrolizumab TDM and immunogenicity research needs in oncology.

📏

I need to measure free pembrolizumab drug levels

Use PEM-FD-KEY for quantitative pembrolizumab measurement. 140-minute sandwich ELISA suitable across all approved indications, both the 200 mg/3-week and 400 mg/6-week dosing schedules.

🔍

I need to screen for anti-pembrolizumab antibodies

Use PEM-QLS-KEY (qualitative bridging ELISA) with validated cut-off controls. Recommended first-tier assay for immunogenicity screening in oncology cohorts across all pembrolizumab indications.

📈

I need to quantify ADA titre longitudinally

Use PEM-QNS-KEY (calibrated bridging ELISA with confirmation reagent) for ADA titre measurement and kinetic profiling over the treatment course.

🎯

I need to characterise neutralising vs. non-neutralising ADA

Use PEM-TCAP-NAb-KEY (T-CAP NAb Assay™). PD-1 target capture detects only ADA blocking pembrolizumab's binding site — functionally relevant for assessing whether ADA may reduce anti-tumour efficacy by preventing PD-1 checkpoint blockade.

⚖️

I need paired drug-level and ADA data

Run PEM-FD-KEY alongside PEM-QLS-KEY or PEM-QNS-KEY. Subtherapeutic drug levels with ADA positivity indicate immunogenic failure; subtherapeutic drug without ADA may reflect non-immunogenic pharmacokinetic variability.

🔬

I need a complete pembrolizumab immunogenicity research panel

Use all four available kits to cover drug levels, qualitative ADA screening, quantitative ADA titre and neutralising antibody characterisation.

Scientific Literature

Publications Using SHIKARI® Pembrolizumab Kits 2

All journal publications below are drawn from the Matrix Biotek Publications library and are shown newest first. Records are included when the publication database identifies the biological drug and SHIKARI® product use.

2026

Vázquez-Quiroga, Sara, et al. "Evaluation of the exposure-response relationship of pembrolizumab in non-small cell lung cancer: observational study protocol in real-world clinical practice." BMC Cancer 26.1 (2026): 630.

Shikari® (Q-PEM) Pembrolizumab ELISA

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2026

Martínez-Toledo, Cristina, et al. "Early Pembrolizumab Plasma Levels as a Prognostic Biomarker in Real-World NSCLC Patients." Pharmacological Research (2026): 108232.

Shikari® (Q-PEM) Pembrolizumab ELISA

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Pembrolizumab Keytruda®

Why Pembrolizumab is relevant to biological-drug monitoring research

Molecular Target & Structure

Approved Indications

Exposure–Response Context

Four kits. Drug levels, qualitative ADA, quantitative ADA and neutralising antibodies.

Kit Specifications at a Glance

Which kit fits your research question?

Publications Using SHIKARI® Pembrolizumab Kits 2

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