Myriad’s BRACAnalysis CDx® Test Successfully Identified Patients with Metastatic Pancreatic Cancer Who Benefitted from Tre...
February 26 2019 - 1:10PM
Myriad Will Seek FDA Approval of
BRACAnalysis CDx as a Companion Diagnostic for
Olaparib in this Patient Population
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized
medicine, today announced that the Phase III POLO study
demonstrated its BRACAnalysis CDx® test successfully
identified patients with metastatic pancreatic cancer who have BRCA
mutations and benefitted from treatment with olaparib, a novel PARP
inhibitor. Myriad plans to file a supplementary Premarket
Approval (sPMA) application with the U.S. Food and Drug
Administration (FDA) to authorize BRCAnalysis CDx as a companion
diagnostic for olaparib in this indication and has an exclusive
commercialization agreement.
“The results of the POLO trial strongly support use of the
BRACAnalysis CDx test to help inform treatment decisions in the
metastatic pancreatic cancer setting and will expand the patient
population who can benefit from BRCA testing,” said Johnathan
Lancaster, M.D., Ph.D., chief medical officer of Myriad
Genetics. “This study underscores Myriad’s commitment to our
pharmaceutical partners and to advancing the field of personalized
medicine for patients with cancer.”
The topline results – announced earlier today by AstraZeneca and
MSD Inc. – are the first reported clinical data from the POLO study
(NCT02184195), which assessed the efficacy of olaparib as
first-line maintenance monotherapy in patients with germline
BRCA-mutated, metastatic pancreatic cancer whose disease had not
progressed on platinum-based chemotherapy. The results
demonstrated a statistically-significant and clinically-meaningful
improvement of progression-free survival (PFS) among BRCA-mutated
patients treated with olaparib compared to placebo.
“We congratulate AstraZeneca and Merck on these exciting study
results and are excited to expand the use of BRACAnalysis CDx in
this patient population,” said Nicole Lambert, general manager,
Myriad Oncology. “Data from multiple clinical studies have
consistently shown that BRACAnalysis CDx can accurately identify
patients for treatment with multiple PARP inhibitors.”
BRACAnalysis CDx is the only FDA-approved germline BRCA1/2
test.
It is estimated there were 466,000 new cases of pancreatic
cancer diagnosed globally in 2018. Germline BRCA-mutated
pancreatic cancer accounts for five to seven percent of all
cases. Pancreatic cancer is the fourth leading cause of
cancer death, and less than seven percent of patients survive more
than five years after diagnosis. Approximately 80 percent of
patients are diagnosed at the metastatic stage.
Olaparib is being commercialized by AstraZeneca and MSD Inc.
(MSD: known as Merck & Co., Inc. inside the US and
Canada). 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 metastatic breast
cancer who are eligible for second-line treatment with
olaparib.
- January 2018: FDA approved BRACAnalysis
CDx as a companion diagnostic to identify patients with metastatic
breast cancer who are eligible for second-line treatment with
olaparib.
- August 2017: FDA approved BRACAnalysis
CDx as a complementary diagnostic to identify patients with ovarian
cancer who are eligible for second-line treatment with
olaparib.
- 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.
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 to 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; 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 |
Investor Contact: |
Scott Gleason |
|
(908) 285-0248 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com |
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