Agilent Technologies, Inc. (NYSE: A) today announced that its PD-L1 IHC 22C3 pharmDx assay is now labeled for use in HNSCC in the European Union.

The assay is CE-IVD–marked as an aid in identifying HNSCC patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumors express PD-L1 with a CPS ≥ 1.

PD-L1 IHC 22C3 pharmDx is the only clinical trial-proven PD-L1 assay CE-IVD–marked as an aid in identifying HNSCC patients for treatment with KEYTRUDA. PD-L1 IHC 22C3 pharmDx is now CE-IVD–marked as a companion diagnostic to KEYTRUDA in three tumor indications – NSCLC, urothelial carcinoma, and HNSCC. In the United States, the FDA approved PD-L1 IHC 22C3 pharmDx in a HNSCC indication in June.

"PD-L1 is an essential biomarker for anti-PD-1 therapies like KEYTRUDA," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "The expanded indication of PD-L1 IHC 22C3 pharmDx will give physicians in Europe critical information to inform first-line treatment decisions for patients with metastatic or unresectable recurrent HNSCC and provide the diagnostic confidence of a clinically relevant test."

HNSCC is the seventh most common cancer worldwide3 and accounts for more than 90% of head and neck cancer cases.4 In Europe, approximately 170,000 new head and neck cancer cases are diagnosed annually.5 Worldwide, the five-year overall survival rate for HNSCC is approximately 40–50%.6

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in collaboration with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC) and urothelial carcinoma patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS). PD-L1 expression in urothelial carcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 expression in HNSCC tissues can be interpreted using CPS and/or TPS.

1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2019.
2. Keytruda [Summary of Product Characteristics]. European Medicines Agency; 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 for 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. World Health Organization. Global Cancer Observatory. (accessed October 9, 2019).
6. World Health Organization. 2014 Review of Cancer Medicines on the WHO List of Essential Medicines: Locally Advanced Squamous Carcinoma of the Head and Neck.
expert/20/applications/HeadNeck.pdf. Published 2014 (accessed October 9, 2019).