Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC)
November 22 2019 - 8:43AM
Business Wire
PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying
HNSCC patients for treatment with KEYTRUDA® (pembrolizumab) in
Europe
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).
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics and applied chemical markets. With more than
50 years of insight and innovation, Agilent instruments, software,
services, solutions, and people provide trusted answers to
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Victoria Wadsworth-Hansen Global Director Public Relations
Agilent Technologies +1 408 553 2005 +45 2933 6980 victoria.wadsworth-hansen@agilent.com
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