LabCorp Announces New Expanded Use for PD-L1 Test with Bristol-Myers Squibb’s OPDIVO®
November 15 2017 - 8:45AM
Business Wire
LabCorp Performed Testing for Studies
Supporting Approval of Two New Complementary Diagnostic Indications
in Connection with the Treatment of Bladder Cancer and Cancer of
the Head and Neck
LabCorp (NYSE: LH) a leading global life sciences company, today
announced the U.S. availability of the PD-L1 IHC 28-8 pharmDx assay
as a complementary diagnostic for two newly approved indications in
connection with the use of Bristol-Myers Squibb’s OPDIVO®
(nivolumab) to treat patients with metastatic urothelial carcinoma,
also referred to as bladder cancer, and squamous cell carcinoma of
the head and neck. The PD-L1 IHC 28-8 pharmDx assay was developed
by Agilent’s Dako pathology division. While OPDIVO is approved for
these indications without use of the test, the test provides
physicians with important information about those patients who are
most likely to respond positively to OPDIVO. LabCorp’s Center for
Molecular Biology and Pathology laboratory performed testing for
the clinical studies that supported approval of the new indications
for the assay.
The PD-L1 IHC 28-8 pharmDx assay was previously approved for use
as a complementary diagnostic with OPDIVO to treat certain patients
with non-squamous non-small cell lung cancer (NSCLC) and melanoma.
LabCorp’s central clinical trials laboratory was the sole provider
of testing to support the clinical trial for the 2015 approval of
the non-squamous NSCLC treatment indication, reflecting how the
combined capabilities of LabCorp’s clinical laboratory
infrastructure and Covance’s central clinical trials laboratory
provide integrated support for clinical trials.
“The expanded use of this PD-L1 test as a complementary
diagnostic for two new cancer indications, as well as our
collaboration in the studies that supported regulatory approval,
demonstrate the unique solutions that only LabCorp can provide for
the development and commercialization of new tests and therapies,
particularly complementary and companion diagnostics,” said David
P. King, chairman and chief executive officer of LabCorp. “The
combined expertise of LabCorp Diagnostics and Covance Drug
Development makes us the industry leader in precision medicine,
including the exciting area of immuno-oncology. With our extensive
experience performing this test, physicians can have high
confidence that the results we deliver will help them identify the
most appropriate treatment for their patients and will improve the
delivery of care.”
The PD-L1 IHC 28-8 pharmDx assay is approved for use with
patients diagnosed with advanced or metastatic bladder cancer, or
recurrent or metastatic squamous cell carcinoma of the head and
neck, whose cancers have returned or progressed after prior
treatment with platinum-based chemotherapy. OPDIVO is an
immunotherapy that helps the immune systems of certain individuals
detect and kill cancer cells. The PD-L1 IHC 28-8 pharmDx assay
identifies a tumor’s expression of the PD-L1 protein, which may be
associated with an increased likelihood of positive immune system
response to treatment with OPDIVO; however, OPDIVO is approved for
use regardless of PD-L1 status.
Squamous cell carcinoma of the head and neck is the most common
form of head and neck cancer, and urothelial carcinoma is the most
common type of bladder cancer, accounting for approximately 90
percent of diagnoses. These cancers are often difficult to treat
using traditional therapies, and immunotherapies like OPDIVO offer
the hope of enhanced survival for appropriate patients.
The PD-L1 IHC 28-8 pharmDx assay is available from LabCorp and
its Integrated Oncology specialty laboratory.
OPDIVO is a registered trademark of Bristol-Myers Squibb
Company.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global
life sciences company that is deeply integrated in guiding patient
care, providing comprehensive clinical laboratory and end-to-end
drug development services. With a mission to improve health and
improve lives, LabCorp delivers world-class diagnostic solutions,
brings innovative medicines to patients faster and uses technology
to improve the delivery of care. LabCorp reported net revenues of
nearly $9.5 billion for 2016. To learn more about LabCorp, visit
www.labcorp.com, and to learn more about Covance Drug Development,
visit www.covance.com.
Forward-Looking Statements
This press release contains forward-looking statements including
with respect to estimated 2017 guidance and the impact of various
factors on operating and financial results. Each of the
forward-looking statements is subject to change based on various
important factors, including without limitation, competitive
actions in the marketplace, and adverse actions of governmental and
other third-party payers. Actual results could differ materially
from those suggested by these forward-looking statements. The
Company has no obligation to provide any updates to these
forward-looking statements even if its expectations change. Further
information on potential factors that could affect operating and
financial results is included in the Company’s Form 10-K for the
year ended December 31, 2016, and subsequent Forms 10-Q, including
in each case under the heading risk factors, and in the Company’s
other filings with the SEC. The information in this press release
should be read in conjunction with a review of the Company’s
filings with the SEC including the information in the Company’s
Form 10-K for the year ended December 31, 2016, and subsequent
Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171115005812/en/
LabCorpMedia Contact:Donald Von Hagen,
336-436-8263orInvestor Contact:Scott Frommer,
336-436-5076
Laboratory Corporation o... (NYSE:LH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Laboratory Corporation o... (NYSE:LH)
Historical Stock Chart
From Apr 2023 to Apr 2024