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PD-L1 IHC 22C3 pharmDx Testing for NSCLC

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PD-L1 is an essential first-line biomarker in NSCLC

In NSCLC, PD-L1 testing with PD-L1 IHC 22C3 pharmDx can help identify patients for first-line treatment with KEYTRUDA

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

  • Lung cancer is the leading cause of cancer-related mortality in the United States, and NSCLC accounts for 85% of all lung cancer cases
  • In 2016, KEYTRUDA became the first anti-PD-1 monotherapy FDA approved at first line for patients with metastatic NSCLC
  • PD-L1 testing provides a direct assessment of PD-L1 expression, which is a biomarker for response to anti-PD-1 therapy in NSCLC
  • PD-L1 testing with PD-L1 IHC 22C3 pharmDx was used to qualify patients with NSCLC for first-line treatment with KEYTRUDA in the KEYNOTE-024 and KEYNOTE-042 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

The only PD-L1 assay used in the KEYTRUDA KEYNOTE-042 clinical trial in NSCLC

PD-L1 IHC 22C3 pharmDx is the FDA-approved companion diagnostic for KEYTRUDA, and was used to assess PD-L1 expression and select patients for treatment in KEYNOTE-042

Percentage calculation based on patients whose tumors expressed PD-L1 (TPS ≥ 1%). Patients whose tumors did not express PD-L1 were not enrolled

PD-L1 IHC 22C3 pharmDx NSCLC Interpretation Manual Refer to the NSCLC Interpretation Manual to review validated scoring guidelines that can aid in the identification of NSCLC patients for treatment with KEYTRUDA
PD-L1 IHC 22C3 pharmDx NSCLC Interpretation Training Program Get the training that may help you accurately evaluate and score PD‑L1 expression in patients with NSCLC
Online Atlas of Stains for NSCLC: PD‑L1 IHC 22C3 pharmDx Use the Online Atlas of Stains for NSCLC to increase your familiarity with PD-L1 staining in NSCLC 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 approved 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 KEYTRUDA9

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 [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2019. 2. Keytruda [package insert]. Kenilworth, NJ: Merck & Co., Inc.; 2019. 3. Noone AM, Howlader N, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2015. National Cancer Institute. November 2017 SEER data submission. Published April 2018. Accessed September 21, 2018. 4. Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small cell lung cancer: Epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008;83(5):584-594. 5. FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Metastatic NSCLC for First-Line Treatment of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) With No EGFR or ALK Genomic Tumor Aberrations; October 24, 2016. Accessed March 22, 2019. 6. Brahmer JR, Govindan R, Anders RA, et al. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC). J Immunother Cancer. 2018;6(1):75. 7. Hanna N, Johnson D, Temin S, et al. Systemic therapy for stage IV non–small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017;35(30):3484-3515. 8. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Onc. 2018;29(4):iv192-iv237. 9. Data on file. Agilent Technologies, Inc.

For countries outside of the United States, 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