Myriad’s myChoice® HRD Test Successfully Identifies Patients that Meet Primary Endpoint in TESARO’s Pivotal Phase 3 Ovar...
June 29 2016 - 7:15AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that its
myChoice® HRD test successfully identified an increased number of
patients with ovarian cancer who may benefit from treatment with
niraparib. Niraparib is an investigational oral PARP
inhibitor being developed by TESARO (Nasdaq:TSRO).
Today’s announcement follows results of the NOVA study
(NCT01847274), which evaluated the safety and efficacy of niraparib
as a maintenance therapy in more than 500 patients with recurrent
ovarian cancer. The primary outcome was the prolongation of
progression-free survival (PFS). Patients were divided into
two groups: those with a germline BRCA mutation and those
without. Patients without a germline BRCA mutation were
evaluated for homologous recombination deficiency (HRD) using
Myriad’s myChoice HRD test. Patients in both groups were randomized
to receive niraparib or placebo.
The study demonstrated that the myChoice HRD test approximately
doubled the number of patients who may benefit from niraparib
treatment than identified by the current FDA-approved BRACAnalysis
CDx® test. Importantly, patients who were germline BRCA
negative, but myChoice HRD positive, experienced over a threefold
increase in median PFS with niraparib compared to placebo.
The key findings are summarized in Table 1.
Table 1: NOVA Study Results
Companion Diagnostic |
Prolonged PFS Benefit (Niraparib vs.
Placebo) |
P-Value |
myChoice HRD positive(germline negative) |
9.1 months(12.9 vs. 3.8 months) |
P<0.0001 |
BRACAnalysis CDx positive (germline positive) |
15.5 months(21.0 vs. 5.5 months) |
P<0.0001 |
“We are very excited about these strong clinical findings as
they demonstrate a new paradigm to personalize PARP inhibitor
treatment,” said Mark Capone, president and CEO, Myriad
Genetics. “We believe the myChoice HRD test is positioned to
become the gold standard companion diagnostic for PARP inhibitors
and will help physicians confidently select safe and effective
treatment plans for their patients.”
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. myChoice HRD expands Myriad’s portfolio
of precision medicine tests.
About myChoice® HRDMyriad's myChoice HRD test
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 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. In December 2014,
BRACAnalysis CDx was approved by the FDA as a companion diagnostic
for Lynparza™ (olaparib) for patients with advanced ovarian cancer
who have had three or more lines of chemotherapy
Conference Call and WebcastA
conference call will be held Thursday, June 30, 2016, at 8:00 a.m.
EDT to discuss the NOVA study results. The dial-in number for
domestic callers is (800) 786-5819. International callers may
dial (303) 223-0117. All callers will be asked to reference
reservation number 21814076. An archived replay of the call
will be available for seven days by dialing (800) 633-8284 and
entering the reservation number above. The conference call,
along with a slide presentation, also will be available through a
live webcast at www.myriad.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
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 and Prolaris 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 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 excitement
about these strong clinical findings and their demonstration of a
new paradigm to personalized PARP inhibitor treatment; the
Company’s belief that the myChoice HRD test is positioned to become
the gold standard diagnostic for PARP inhibitors and will help
physicians confidently select safe and effective treatment plans
for their patients; the development of myChoice HRD testing,
including several ongoing clinical trials, with the clinical
development of niraparib; and the Company's strategic directives
under the captions “About myChoice HRD,” “About BRACAnalysis CDx,”
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, 2015, 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
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