Myriad's myChoice® HRD Test Identifies Patients with Ovarian Cancer Who May Benefit from Treatment with Niraparib
October 08 2016 - 2:30AM
SALT LAKE CITY, Oct. 08, 2016 (GLOBE NEWSWIRE)
-- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that its
myChoice® HRD test
identified more than double the number of patients who may benefit
from treatment with niraparib than were identified by
germline BRCA testing alone.
The myChoice HRD test was evaluated in the NOVA study (NCT01847274)
of nirarapib, an investigational oral PARP inhibitor being
developed by TESARO (Nasdaq:TSRO).
Today's announcement follows publication of the
NOVA study in the New England Journal of
Medicine. NOVA is a well-controlled Phase 3 trial of
niraparib that enrolled 553 patients with recurrent ovarian cancer
who responded to their most recent platinum-based chemotherapy.
This trial was designed to assess progression free survival (PFS)
in a broad population of patients who were assigned to one of two
cohorts based upon germline BRCA mutation status.
"Patients with ovarian cancer who tested positive
with myChoice HRD experienced a clinically meaningful improvement
in PFS," said Johnathan Lancaster, M.D., Ph.D., gynecologic
oncologist and chief medical officer of Myriad Genetic
Laboratories. "We estimate that myChoice HRD identifies more
than double the number of patients who may benefit compared to
germline BRCA testing
alone."
The NOVA results showed that in patients who were
germline BRCA mutation carriers, the
median PFS for patients treated with niraparib was 21.0 months
compared to 5.5 months for the control group (p<0.0001; HR
0.27,95% CI, 0.173-0.410). The median PFS benefit for patients with
HRD-positive tumors who were treated with niraparib was 12.9 months
compared to 3.8 months for the control group (P<0.0001; HR 0.38,
95% CI, 0.243-0.586). Additionally, the exploratory analysis
showed that for patients who were determined to be HRD negative,
the median PFS for patients treated with niraparib was 6.9 months
compared to 3.8 months for the control group (p<0.0226; HR 0.58,
95% CI, 0.361-0.922).
The key findings are illustrated in the chart
below.
http://www.globenewswire.com/NewsRoom/AttachmentNg/e05f7572-2d8d-48c8-80b4-4a2ad412e9db
The myChoice HRD test is being developed in
parallel with the clinical development of niraparib. The
collaboration with TESARO began in March 2014 and includes several
ongoing clinical trials in a variety of tumor types.
About myChoice® HRD
Myriad's myChoice HRD is the most comprehensive homologous
recombination deficiency test to detect when a tumor has lost the
ability to repair double-stranded DNA breaks, resulting in
increased susceptibility to DNA-damaging drugs such as platinum
drugs or PARP inhibitors. The myChoice HRD score is a
composite of three proprietary technologies: loss of
heterozygosity, telomeric allelic imbalance and large-scale state
transitions. Positive myChoice HRD scores, reflective of DNA
repair deficiencies, are prevalent in all breast cancer subtypes,
ovarian and most other major cancers. In previously published
data, Myriad showed that the myChoice HRD test predicted drug
response to platinum therapy in certain patients with
triple-negative breast and ovarian cancers. It is estimated
that 1.4 million people in the United States and Europe who are
diagnosed with cancers annually may be candidates for treatment
with DNA-damaging agents.
About Myriad
Genetics
Myriad 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 three strategic
imperatives: transitioning and expanding its hereditary
cancer testing markets, diversifying its product portfolio through
the introduction of new products and increasing the revenue
contribution from international markets. 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, Vectra, Prolaris and
GeneSight 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 Statement
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements related to the ability of the myChoice HRD
test to identify an increased number of patients with ovarian
cancer who may benefit from treatment with niraparib; the Company's
estimate that myChoice HRD identifies double the number of patients
compared to germline BRCA testing
alone; the importance of the myChoice HRD test for this
patient population; and the Company's strategic directives under
the captions "About myChoice HRD," and "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; 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, 2016, 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) 584-1143
sgleason@myriad.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Myriad Genetics, Inc. via Globenewswire
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