Myriad’s myChoice® HRD Test Identifies Patients with Ovarian Cancer Who May Benefit from Treatment with Niraparib
October 08 2016 - 2:30AM
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® HRDMyriad'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 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, 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 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 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
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