Press release

Agilent Companion Diagnostic Gains Expanded FDA Approval in Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsored by Businesswire

Technologies Inc.
(NYSE: A) today announced that the U.S. Food and
Drug Administration (FDA) has approved its PD-L1 IHC 22C3 pharmDx assay
for expanded use.

The assay is now approved as an aid in identifying patients with head
and neck squamous cell carcinoma (HNSCC) for treatment with KEYTRUDA®
(pembrolizumab), anti-PD-1 therapy manufactured by Merck (known as MSD
outside the United States and Canada). KEYTRUDA, as a single agent, is
indicated for the first-line treatment of patients with metastatic or
with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥ 1)
as determined by an FDA-approved test.

PD-L1 IHC 22C3 pharmDx is the only companion diagnostic FDA-approved to
aid in the identification of HNSCC patients for treatment with KEYTRUDA.
HNSCC is the fifth cancer type for which PD-L1 IHC 22C3 pharmDx has
gained FDA approval in the United States.

“Targeted immunotherapies are redefining standards of care in cancer
treatment, and PD-L1 testing plays a crucial role in identifying
patients who may benefit from this treatment,” said Sam Raha, president
of Agilent’s Diagnostics and Genomics Group. “The expanded FDA approval
of PD-L1 IHC 22C3 pharmDx provides critical information to physicians
managing first-line treatment of patients with metastatic or with
unresectable, recurrent HNSCC. By expanding the use of PD-L1 IHC 22C3
pharmDx, Agilent enables more patients to be identified for treatment
with KEYTRUDA. Through these efforts, we reinforce our role as a
worldwide leader in driving companion diagnostics to market in support
of landmark therapies.”

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 annually.5,6 The five-year overall survival
rate for this form of cancer is approximately 40–50 percent.7

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 partnership with
Merck & Co. PD-L1 IHC 22C3 pharmDx also helps physicians identify
non-small cell lung cancer (NSCLC), cervical cancer, gastric or GEJ
adenocarcinoma, 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 HNSCC, urothelial carcinoma,
cervical cancer, and gastric or GEJ adenocarcinoma tissues is
interpreted using Combined Positive Score (CPS).

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences,
diagnostics, and applied chemical markets. Based on more than 50 years
of insight and innovation, Agilent instruments, software, services,
solutions, and people provide trusted answers to customers’ most
challenging questions. The company generated revenues of $4.91 billion
in fiscal 2018 and employs 15,550 people worldwide. Information about
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1.   PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako,
Agilent Pathology Solutions; 2019.

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 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. 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. World Health Organization. 2014 Review of Cancer Medicines on the
WHO List of Essential Medicines: Locally Advanced Squamous Carcinoma
of the Head and Neck.
Published 2014 (accessed January 25, 2019).