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PD-L1 IHC 22C3 pharmDx Testing for TNBC

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PD-L1 is an essential biomarker in metastatic TNBC

In TNBC, PD-L1 testing with PD-L1 IHC 22C3 pharmDx (SK006) can help identify patients for treatment with KEYTRUDA1,2

  • In Europe, breast cancer is the most common type of cancer diagnosed in women,3 and approximately 15–20% of breast cancer diagnoses are TNBC.4 Patients with TNBC have significantly worse overall survival times than non-TNBC patients5
  • PD-L1 testing provides a direct assessment of PD-L1 expression, which is a biomarker for response to anti-PD-1 therapy in TNBC1,2
  • In the KEYNOTE-355 clinical trial, PD-L1 testing with PD-L1 IHC 22C3 pharmDx was used to assess PD-L1 expression in patients with previously untreated locally recurrent unresectable or metastatic TNBC, who had not received prior chemotherapy for metastatic disease*1,2

* Review the PD-L1 IHC 22C3 pharmDx Instructions for Use for more information regarding the KEYNOTE clinical trials

Learn more about
PD-L1 IHC 22C3 pharmDx:
PD-L1 IHC 22C3 pharmDx is the ONE assay used to assess PD-L1 status across KEYTRUDA clinical trials

PD-L1 IHC 22C3 pharmDx was the only PD-L1 assay used in the KEYTRUDA KEYNOTE-355 clinical trial in TNBC1,2

PD-L1 IHC 22C3 pharmDx is CE-IVD–marked as the clinical trial‑proven companion diagnostic for KEYTRUDA1

For clinically relevant PD-L1 results in TNBC, use PD-L1 IHC 22C3 pharmDx

Chemotherapy: paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin

KN355 Trial Data
PD-L1 IHC 22C3 pharmDx TNBC Interpretation Manual Image of the PD-L1 IHC 22C3 pharmDx TNBC Interpretation Manual Refer to the TNBC Interpretation Manual to review validated scoring guidelines that can aid in the identification of TNBC patients for treatment with KEYTRUDA
Online Atlas of Stains for TNBC: PD-L1 IHC 22C3 pharmDx Image of the PD-L1 IHC 22C3 pharmDx TNBC Online Atlas of Stains Use the Online Atlas of Stains for TNBC to increase your familiarity with PD-L1 staining in TNBC specimens
Pursue lab excellence with the leading PD-L1 assay for KEYTRUDA

When confidence in a PD-L1 test is critical, the ONE you choose is crucial

  • The ONE PD-L1 assay used in KEYTRUDA clinical trials1,2
  • The ONE PD-L1 assay first launched with KEYTRUDA in every indication that requires PD-L1 testing1,2
  • The ONE PD-L1 assay trusted worldwide to test hundreds of thousands of patients for KEYTRUDA6
Choose PD-L1 IHC 22C3 pharmDx - the ONE leading assay with KEYTRUDA
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KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

References: 1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2021. 2. Keytruda [Summary of Product Characteristics]. European Medicines Agency; 2021. 3. World Health Organization. Global Cancer Observatory. (accessed April 27, 2022). 4. Ismail-Khan R, Bui MM (2010) A review of triple-negative breast cancer. Cancer Control 17(3):173–176. 5. Li, X.; Yang, J.; Peng, L.; Sahin, A. A.; Huo, L.; Ward, K. C.; O’Regan, R.; Torres, M. A.; Meisel, J. L. Triple-Negative Breast Cancer Has Worse Overall Survival and Cause-Specific Survival than Non-Triple-Negative Breast Cancer. Breast Cancer Res Treat. 2016, 161(2), 279–287. 6. Data on file. Agilent Technologies, Inc.

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


Review the PD-L1 IHC 22C3 pharmDx Intended Use