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

June 11, 2019 Off By BusinessWire

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

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References:

1.   PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako,
Agilent Pathology Solutions; 2019.
2.

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.
https://www.who.int/selection_medicines/committees/expert/20/applications/HeadNeck.pdf.
Published 2014 (accessed January 25, 2019).

Contacts

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