Myriad's myChoice® HRD Test Identifies Patients with Ovarian Cancer Who May Benefit from Treatment with Niraparib
(Thomson Reuters ONE) -
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(at)myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason(at)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
Unternehmensinformation / Kurzprofil:
Datum: 08.10.2016 - 08:30 Uhr
Sprache: Deutsch
News-ID 499482
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"Myriad's myChoice® HRD Test Identifies Patients with Ovarian Cancer Who May Benefit from Treatment with Niraparib"
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