Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized
medicine, today announced that its BRACAnalysis CDx® companion
diagnostic test effectively identified patients with metastatic
pancreatic cancer who benefitted from treatment with Lynparza®
(olaparib) in the Phase III POLO study. Results of this
important study were featured today at the 2019 American Society of
Clinical Onocology (ASCO) meeting in Chicago.
“Our long-standing collaboration with Myriad Genetics Inc. has
enabled us to deliver the positive POLO study in pancreatic cancer
patients, demonstrating our shared ambition to target precision
medicines to the right patients across different cancers,” said
Ruth March, Ph.D., senior vice president and head of Precision
Medicine, Oncology R&D, AstraZeneca.
Specifically, the POLO study demonstrated that patients with a
germline mutation, and whose disease had not progressed on
first-line platinum-based chemotherapy, had a clinically-meaningful
and statistically-significant improvement in progression-free
survival (PFS) of 7.4 months when treated with Lynparza®
compared to 3.8 months for placebo (HR 0.53; p=0.004).
Lynparza is a novel PARP inhibitor being commercialized by
AstraZeneca (LSE/STO/NYSE: AZN) and Merck (known as MSD
outside the U.S.) and is not currently approved by the U.S. Food
and Drug Administration (FDA) for gBRCAm pancreatic cancer.
“The POLO study demonstrated the clinical effectiveness of the
BRACAnalysis CDx test to identify germline BRCA mutations and
enable transformative precision therapy for patients with
pancreatic cancer," said Johnathan Lancaster, M.D., Ph.D., chief
medical officer, Myriad Genetics. “The message for clinicians
is clear: all patients with pancreatic cancer should receive a
BRACAnalysis CDx test to determine their BRCA
status.”
New NCCN Guidelines Recommend Genetic Testing for All
Patients with Pancreatic Cancer In February, the National
Comprehensive Cancer Network (NCCN) updated its guidelines to
recommend universal germline BRCA testing for all patients with
pancreatic cancer. Pancreatic cancer is the third most common
cause of cancer-related death in the United States, and it is
estimated that germline BRCA-mutated pancreatic cancer accounts for
approximately seven percent of all cases.
“Based on the new NCCN guidelines, clinicians should order a
BRACAnalysis CDx test for their patients with pancreatic cancer at
the time of diagnosis,” said Dr. Lancaster. “The sooner we
can identify patients with germline BRCA mutations, the better
chance they will have to benefit from precision therapies.”
Myriad previously announced that it intends to file a
supplementary Premarket Approval (sPMA) application with the FDA to
authorize BRACAnalysis CDx as a companion diagnostic for Lynparza
in patients with pancreatic cancer. The Company also has
signed an exclusive commercialization agreement with
AstraZeneca.
“We congratulate AstraZeneca and Merck on the POLO study results
and look forward to collaborating with them to improve outcomes for
patients with pancreatic cancer,” said Nicole Lambert, president,
Myriad Oncology. “BRACAnalysis CDx is the only test approved
by FDA to identify germline BRCA mutations, and the POLO study
highlights our ongoing commitment to improve outcomes for people
with difficult-to-treat cancers.”
The collaboration between Myriad and AstraZeneca on olaparib
began in 2007 and has resulted in multiple regulatory approvals for
BRACAnalysis CDx.
- December 2018: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients newly diagnosed with
advanced ovarian cancer who are eligible for first-line maintenance
treatment with olaparib.
- March 2018: The Japanese Ministry of
Health, Labour, and Welfare approved BRACAnalysis CDx as a
companion diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible for treatment
with Lynparza.
- January 2018: FDA approved BRACAnalysis
CDx as a companion diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible treatment
with Lynparza.
- August 2017: FDA approved BRACAnalysis
CDx as a complementary diagnostic to identify patients with
recurrent platinum-sensitive germline BRCAm ovarian cancer who
are eligible for maintenance treatment with Lynparza.
- Dec. 2014: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients with advanced
ovarian cancer who are eligible for fourth-line treatment with
olaparib.
About BRACAnalysis CDx®BRACAnalysis CDx is an
in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and
intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic
DNA obtained from whole blood specimens collected in EDTA.
Single nucleotide variants and small insertions and deletions
(indels) are identified by polymerase chain reaction (PCR) and
Sanger sequencing. Large deletions and duplications in BRCA1
and BRCA2 are detected using multiplex PCR. This assay is for
professional use only and is to be performed only at Myriad Genetic
Laboratories, a single laboratory site located at 320 Wakara Way,
Salt Lake City, UT 84108. Learn more at:
http://myriadmychoice.com/.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
five strategic imperatives: build upon a solid hereditary
cancer foundation, growing new product volume, expanding
reimbursement coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. For more information on how Myriad is making a
difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris,
ForeSight and Prequel are trademarks or registered trademarks of
Myriad Genetics, Inc. or its wholly owned subsidiaries in the
United States and foreign countries. MYGN-F, MYGN-G.
Lynparza is a registered trademark of AstraZeneca.
Safe Harbor StatementThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements related to the results of the POLO Study being reported
at the 2019 ASCO meeting; the ability of the BRACAnalysis CDx test
to identify patients with pancreatic cancer who may benefit from
treatment with olaparib; the importance of the BRACAnalysis
CDx test for this patient population and the ability to identify
patients likely to benefit from PARP inhibition therapy; messaging
to clinicians that all patients with pancreatic cancer should
receive a BRACAnalysis CDx test to determine their BRCA status;
clinicians ordering a BRACAnalysis CDx test for their patients with
pancreatic cancer at the time of diagnosis based on NCCN
guidelines; looking forward to collaborating with AstraZeneca and
Merck to improve outcomes for patients with pancreatic cancer; and
the Company's strategic directives under the caption "About Myriad
Genetics." These "forward-looking statements" are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our molecular diagnostic tests and
pharmaceutical and clinical services may decline; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in governmental or private insurers’
reimbursement levels for our tests or our ability to obtain
reimbursement for our new tests at comparable levels to our
existing tests; risks related to increased competition and the
development of new competing tests and services; the risk that we
may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and pharmaceutical and
clinical services in a timely manner, or at all; the risk that we
may not successfully develop new markets for our molecular
diagnostic tests and pharmaceutical and clinical services,
including our ability to successfully generate revenue outside the
United States; the risk that licenses to the technology underlying
our molecular diagnostic tests and pharmaceutical and clinical
services and any future tests and services are terminated or cannot
be maintained on satisfactory terms; risks related to delays or
other problems with operating our laboratory testing facilities and
our healthcare clinic; risks related to public concern over genetic
testing in general or our tests in particular; risks related to
regulatory requirements or enforcement in the United States and
foreign countries and changes in the structure of the healthcare
system or healthcare payment systems; risks related to our ability
to obtain new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; the
risk that we or our licensors may be unable to protect or that
third parties will infringe the proprietary technologies underlying
our tests; the risk of patent-infringement claims or challenges to
the validity of our patents or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical services
and patents or enforcement in the United States and foreign
countries, such as the Supreme Court decision in the lawsuit
brought against us by the Association for Molecular Pathology et
al; risks of new, changing and competitive technologies and
regulations in the United States and internationally; the risk that
we may be unable to comply with financial operating covenants under
our credit or lending agreements; the risk that we will be
unable to pay, when due, amounts due under our credit or lending
agreements; and other factors discussed under the heading "Risk
Factors" contained in Item 1A of our most recent Annual Report on
Form 10-K for the fiscal year ended June 30, 2018, which has been
filed with the Securities and Exchange Commission, as well as any
updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form
8-K. All information in this press release is as of the date
of the release, and Myriad undertakes no duty to update this
information unless required by law.
Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott
Gleason(801) 584-1143sgleason@myriad.com
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