Technologies Inc. (NYSE: A) today announced that the U.S. Food and
Drug Administration has updated its approval of the company’s PD-L1 IHC
22C3 pharmDx assay.
The assay can now be used as a companion diagnostic to identify a
broader range of patients with stage III or metastatic non-small cell
lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted
anti-PD-1 therapy manufactured by Merck & Co. (known as MSD outside the
United States and Canada).
The FDA previously approved the assay to identify metastatic NSCLC
patients whose tumors express PD-L1 Tumor Proportion Score (TPS) ≥ 50%
for first-line treatment with KEYTRUDA. Now, patients with stage III
NSCLC who are not candidates for surgical resection or definitive
chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 TPS
≥ 1% are eligible for first-line treatment. This expanded indication
enables pathologists to identify a larger population of previously
untreated patients who are now eligible for treatment with KEYTRUDA.
“Anti-PD-1 therapies are a promising treatment class for many cancer
types, and PD-L1 testing provides key information to physicians managing
stage III or metastatic NSCLC patients,” said Sam Raha, president of
Agilent’s Diagnostics and Genomics Group. “The updated FDA approval of
PD-L1 IHC 22C3 pharmDx broadens the scope of patients that can be
identified for first-line treatment with KEYTRUDA and offers new hope to
the many patients diagnosed with stage III or metastatic NSCLC. By
expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to continue
our legacy of pioneering companion diagnostics to support the launch of
Lung cancer is the leading cause of cancer-related mortality in the
United States, with an estimated incidence of 154,000 deaths in 2018
alone.1 Among these cases, NSCLC accounts for nearly 85% of
all diagnoses, and carries a 5-year survival rate of 15%.2
PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and
pathology labs play an important role in identifying appropriate
patients for these treatments.
Agilent’s PD-L1 IHC 22C3 pharmDx is the first and only companion
diagnostic that has been clinically validated and approved to identify
NSCLC patients eligible for KEYTRUDA.
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
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
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. With 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 15,300 people worldwide. Information about
Agilent is available at www.agilent.com.
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1. Noone AM, Howlader N, Krapcho M, et al. SEER Cancer Statistics
Review, 1975-2015. National Cancer Institute. https://seer.cancer.gov/csr/1975_2015/.
November 2017 SEER data submission. Published April 2018. Accessed
September 21, 2018.
2. Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small
cell lung cancer: Epidemiology, risk factors, treatment, and
survivorship. Mayo Clin Proc. 2008;83(5):584-594.