Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC)

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.

References:
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. http://gco.iarc.fr/today/data/factsheets/populations/994-who-europe-region-euro-fact-sheets.pdf (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. https://www.who.int/selection_medicines/committees/expert/20/applications/HeadNeck.pdf. Published 2014 (accessed October 9, 2019).

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