Head and Neck Squamous Cell Carcinoma (HNSCC): PD-L1 IHC 22C3 pharmDx
In HNSCC, PD-L1 testing with PD-L1 IHC 22C3 pharmDx can help identify patients for first-line treatment with KEYTRUDA1,2
- HNSCC is the seventh most common cancer worldwide3 and accounts for more than 90% of head and neck cancer cases.4 In the United States, approximately 65,000 new head and neck cancer cases are diagnosed annually5,6
- PD-L1 testing provides a direct assessment of PD-L1 expression, which is a biomarker for response to anti-PD-1 therapy in HNSCC1,2
- PD-L1 testing with PD-L1 IHC 22C3 pharmDx was used to assess PD-L1 expression in patients with metastatic or recurrent HNSCC in the KEYNOTE-048 clinical trial*1,2
* Review the PD-L1 IHC 22C3 pharmDx Instructions for Use for more information regarding the KEYNOTE clinical trials
The only PD-L1 assay used in the KEYTRUDA KEYNOTE-048 clinical trial in HNSCC1,2
PD-L1 expression in KEYNOTE-048 was determined by PD-L1 IHC 22C3 pharmDx, the FDA-approved companion diagnostic for KEYTRUDA1
† In the KEYTRUDA single agent and control arms
‡ Cetuximab, platinum, and FU
Note: PD-L1 expression level CPS ≥ 20 may be of interest to treating physician but does not determine eligibility for first-line treatment with KEYTRUDA as a single agent.
Forty-three percent of patients had tumors that expressed PD-L1 with CPS ≥ 20 (prevalence calculation based on patients with known PD-L1 expression [N=597]; 4 patients had unknown PD-L1 expression status). Median overall survival of patients in the CPS ≥ 20 subgroup was 14.9 months in the KEYTRUDA single agent arm, as compared to 10.7 months in the control arm.
Refer to the HNSCC Interpretation Manual to review validated scoring guidelines that can aid in the identification of HNSCC patients for treatment with KEYTRUDA 
Get the training that may help you accurately evaluate and score PD‑L1 expression in patients with HNSCC 
Use the Online Atlas of Stains for HNSCC to increase your familiarity with PD-L1 staining in HNSCC specimens 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 KEYTRUDA7
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. Seiwert, T.Y.; Burtness, B.; Mehra, R.; Weiss, J.; Berger, R.; Eder, J.P.; Heath, K.; McClanahan, T.; Lunceford, J.; Gause, C.; Cheng, J.D.; Chow, L.Q. Safety And Clinical Activity of Pembrolizumab or Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (KEYNOTE-012): An Open-label, Multicenter, Phase 1b Trial. Lancet Oncol. 2016, 17 (7), 956-965. 4. Gupta, B.; Johnson, N.W.; Kumar, N. Global Epidemiology of Head and Neck Cancers: A Continuing Challenge. Oncology. 2016, 91, 13-23. 5. Siegel, R.L.; Miller, K.D.; Jemal, A. Cancer Statistics, 2018. CA Cancer J. Clin. 2018, 68 (1), 7-30. 6. Siegel, R.L.; Miller, K.D.; Jemal, A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019, 69 (1), 7-34. 7. 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.D54671/01.1
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