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Your Report.
A Patient’s Future.

The PD-L1 result you report with CPS could be a lifeline for patients.
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Watch the new CPS scoring video: Evaluating the CPS Denominator

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PD-L1 status with CPS (Combined Positive Score) directly impacts a patient’s potential treatment future.

For certain patients whose tumors express PD-L1, KEYTRUDA® (pembrolizumab), an anti-PD-1 treatment, has demonstrated superior survival and tumor response in clinical trials relative to standard treatments1,2

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* Cetuximab, platinum, and FU; † Excludes patients with unknown PD-L1 status

“Based on the clinical trial assay, incorporation of inflammatory cells into the determination of PD-L1 positivity versus the use of tumor cells alone seemed to be crucial for detecting responders” 4
- Plimack et al. -

Your score. A patient’s response.

PD-L1 scoring systems are not interchangeable

  • When considering patients for treatment with KEYTRUDA, use the assay and scoring system proven in the KEYNOTE clinical trials to deliver reliable and clinically relevant diagnostic results
  • CPS measures tumor and immune cells, which are both crucial in determining PD-L1 expression for patients being considered for treatment with KEYTRUDA in certain tumor types3
  • External reproducibility assessments of CPS demonstrated up to 95.7% interpathologist and up to 97.8% intrapathologist overall agreement across CPS KEYNOTE trials1

In every KEYNOTE study with CPS, cut-offs were precisely calibrated to identify the optimal patient population for treatment with KEYTRUDA

Clinical Trial
Tumor Type Cut-off PD-L1 Prevalence in KEYNOTE Trial
KEYNOTE-048 HNSCC CPS ≥ 1 85%
KEYNOTE-052 Urothelial Carcinoma CPS ≥ 10 30%

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Watch the new CPS scoring video: Evaluating the CPS Denominator

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Want to learn more about PD-L1 IHC 22C3 pharmDx? Contact an Agilent representative:

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Your choices. A patient’s outcomes.

A PD-L1 workflow can be set up in countless configurations. Why settle for an approach that isn’t trial-proven?

  • PD-L1 IHC 22C3 pharmDx is the one PD-L1 assay used in KEYTRUDA clinical trials1,2
  • PD-L1 IHC 22C3 pharmDx is a complete, integrated system, with all necessary components for a staining run validated together1,5
  • PD-L1 IHC 22C3 pharmDx is highly repeatable and reproducible, delivering reliable, high-quality stains1,5
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Review the PD-L1 IHC 22C3 pharmDx Intended Use

Intended Use

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

References. 1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2020. 2. Keytruda [Summary of Product Characteristics]. European Medicines Agency; 2020. 3. Emancipator, K.; Juco, J.; Huang, L.; Lunceford, J.; Cheng, J.; Ge, J.; Gause, C.; Swaby, R. F. Choice of PD-L1 Scoring and Cutoff in Head and Neck Squamous Cell Carcinoma (HNSCC) Trials of Pembrolizumab. USCAP 2020 Annual Meeting. 4. Plimack, E. R.; Bellmunt, J.; Gupta, S.; Berger, R.; Chow, L. Q. M.; Juco, J.; Lunceford, J.; Saraf, S.; Perini, R. F.; Odonnell, P. H. Safety and Activity of Pembrolizumab in Patients with Locally Advanced or Metastatic Urothelial Cancer (KEYNOTE-012): a Non-Randomised, Open-Label, Phase 1b Study. The Lancet Oncology 2017, 18 (2), 212–220. 5. Roach, C.; Zhang, N.; Corigliano, E.; Jansson, M.; Toland, G.; Ponto, G.; Dolled-Filhart, M.; Emancipator, K.; Stanforth, D.; Kulangara, K. Development of a Companion Diagnostic PD-L1 Immunohistochemistry Assay for Pembrolizumab Therapy in Non–Small-Cell Lung Cancer. Applied Immunohistochemistry & Molecular Morphology 2016, 24 (6), 392–397.

For countries outside of the European Union, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.