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

PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify HNSCC
patients for treatment with KEYTRUDA^® (pembrolizumab)

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent
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,
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of insight and innovation, Agilent instruments, software, services,
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Contacts

Victoria Wadsworth-Hansen
Agilent Technologies
+1 408 553 2005
+45
2933 6980
[email protected]