Market Overview

Agilent Companion Diagnostic Gains Expanded FDA Approval in Urothelial Carcinoma


PD-L1 IHC 22C3 pharmDx Now Approved to Identify Certain Urothelial
Carcinoma Patients for Treatment With KEYTRUDA
® (pembrolizumab)

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

The assay is now approved to identify patients with urothelial carcinoma
who may benefit from KEYTRUDA, an anti-PD-1 therapy manufactured by
Merck (known as MSD outside the United States and Canada), as a
first-line treatment option. KEYTRUDA is approved for patients with
locally advanced or metastatic urothelial carcinoma who are not eligible
for cisplatin-containing chemotherapy and whose tumors express PD-L1
[Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved
test, or in patients who are not eligible for any platinum-containing
chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to
identify patients with urothelial carcinoma for treatment with KEYTRUDA.
This follows previous FDA approvals for PD-L1 IHC 22C3 pharmDx in
non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction
(GEJ) adenocarcinoma, and cervical cancer.

"Anti-PD-1 therapies are a promising treatment class for many cancer
types, and early PD-L1 testing can provide critical information to
physicians managing urothelial carcinoma patients," said Sam Raha,
president of Agilent's Diagnostics and Genomics Group. "By expanding the
use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need
for treatment options in patients who are ineligible for
cisplatin-containing chemotherapy. Through these efforts, we maintain
our commitment to bringing companion diagnostics to the market in
support of groundbreaking immuno-oncology therapeutics."

Urothelial carcinoma is the fifth most common cancer in the United
States, with an estimated incidence of 81,000 new cases in 2018 alone.1
For patients with advanced/metastatic urothelial carcinoma,
cancer-related mortality has not improved in the past 30 years and the
five-year survival rate is approximately 15%.2 Additionally,
age- and disease-associated comorbidities affect patient eligibility for
standard cisplatin-containing chemotherapy.3-5 For patients
ineligible for cisplatin-containing chemotherapy, there is a significant
unmet need for new, effective treatments.3,4

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. PD-L1 IHC 22C3 pharmDx also helps physicians identify NSCLC,
cervical cancer, and gastric or GEJ adenocarcinoma patients for
treatment with KEYTRUDA. PD-L1 expression in urothelial carcinoma,
cervical cancer, and gastric or GEJ adenocarcinoma tissues is
interpreted using Combined Positive Score (CPS). PD-L1 expression in
NSCLC tissues is interpreted using Tumor Proportion Score (TPS).

References: 1. Noone AM, Howlader N, Krapcho M, Miller D, Brest
A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ,
Cronin KA, eds. SEER Cancer Statistics Review, 1975-2015. National
Cancer Institute.
November 2017 SEER data submission. Published April 2018. Accessed
August 16, 2018. 2. Gupta S, Gill D, Poole A, Agarwal N. Systemic
immunotherapy for urothelial cancer: current trends and future
directions. Cancers. 2017;9(15):1-14. 3. Bellmunt J,
Mottet N, De Santis M. Urothelial carcinoma management in elderly or
unfit patients. EJC Suppl. 2016;14(1):1-20. 4. Balar AV,
Castellano D, O'Donnell PH, et al. First-line pembrolizumab in
cisplatin-ineligible patients with locally advanced and unresectable or
metastatic urothelial cancer (KEYNOTE-052): A multicentre, single-arm,
phase 2 study. Lancet. 2017;18(11):1483-1492. 5. Galsky
MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic
urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin
. 2011;29(17):2432-2438.

About Agilent Technologies

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