Myriad’s BRACAnalysis CDx® Test Identified Patients with Metastatic Breast Cancer Who Benefited from Treatment with Olapar...
June 04 2017 - 7:30AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that its
BRACAnalysis CDx® companion diagnostic test successfully
identified BRCA-mutated patients with HER2- metastatic breast
cancer in the OlympiAD trial (NCT02000622) who responded better to
treatment with olaparib than standard chemotherapy.
OlympiAD compared olaparib (300mg twice daily) to physician’s
choice of a standard chemotherapy (capecitabine, vinorelbine or
eribulin) in the treatment of 302 patients with HER2-negative
metastatic breast cancer harboring germline
BRCA1/2 mutations as determined by Myriad’s BRACAnalysis CDx
companion diagnostic test. The results showed that
BRCA-positive patients treated with olaparib had a
statistically-significant and clinically-meaningful PFS benefit of
compared to the control group.
“In this study, patients with BRCA mutations experienced
significantly prolonged PFS when treated with olaparib versus
standard of care chemotherapy,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetic Laboratories.
“Based on these findings, all patients with metastatic breast
cancer should know their BRCA status as it will be a critical
factor in guiding therapy selection for patients with metastatic
breast cancer.”
It is estimated there are approximately 60,000 patients per year
in the United States who are newly diagnosed with or progress to
HER2- metastatic breast cancer. Of these patients, two-thirds
are not eligible for BRCA testing based upon current testing
criteria. If approved by the FDA as a new indication this
would potentially triple the number of patients with metastatic
breast cancer who are candidates for BRCA testing.
“We believe the results from the OlympiAD study will expand the
population who can benefit from the BRACAnalysis CDx test, and the
results will help doctors improve care for their patients with
metastatic breast cancer,” said Lancaster. “This study
further supports the use of advanced biomarkers, like BRACAnalysis
CDx, to enable precision medicine, which benefits both patients and
the healthcare ecosystem.”
The collaboration between Myriad and AstraZeneca to develop a
novel companion diagnostic test for olaparib began in 2007.
OlympiAD is the first Phase 3 trial to demonstrate the clinical
utility of the BRACAnalysis CDx test outside of ovarian cancer for
which the test was approved by the U.S. Food and Drug
Administration (FDA) in Dec. 2014. Based on the robustness of
the OlympiaAD results, Myriad plans to submit a supplementary
premarket approval (sPMA) application under its existing PMA for
BRACAnalysis CDx to include the HER2- metastatic breast cancer
indication.
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. Results of the
test are used as an aid in identifying ovarian cancer patients with
deleterious or suspected deleterious germline BRCA variants, who
are or may become eligible for treatment with Lynparza™ (olaparib).
This assay is for professional use only and is to be performed only
at 320 Wakara Way, Salt Lake City, UT 84108.
About LynparzaLynparza (olaparib) is an
innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that may exploit tumour DNA damage response (DDR) pathway
deficiencies to preferentially kill cancer cells. Lynparza is the
foundation of AstraZeneca’s industry-leading portfolio of compounds
targeting DNA damage response (DDR) mechanisms in cancer cells.
Lynparza is currently approved by regulatory health authorities in
the EU for use as monotherapy for the maintenance treatment of
adult patients with platinum-sensitive relapsed BRCA-mutated
(germline and/or somatic) high grade serous epithelial ovarian,
fallopian tube or primary peritoneal cancer who are in response
(complete or partial) to platinum-based chemotherapy. It is also
approved in the US as monotherapy in patients with deleterious or
suspected deleterious germline BRCA-mutated (as detected by an
FDA-test) advanced ovarian cancer who have been treated with three
or more prior lines of chemotherapy. Lynparza is currently being
investigated in another separate non-metastatic breast cancer Phase
III study called OLYMPIA. This study is still open and recruiting
patients internationally.
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 BRACAnalysis CDx test to successfully
identify metastatic breast cancer patients with improved outcomes
from olaparib; the results of the study demonstrating a
statistically-significant improvement of progression-free survival
(PFS) among BRCA-mutated patients treated with olaparib
compared to those treated with physicians’ choice; the Company’s
belief that the results of the OlympiAD trial support use of the
BRACAnalysis CDx test to help inform treatment decisions in the
metastatic breast cancer setting and will expand the patient
population who can benefit from BRCA testing; the importance of the
BRACAnalysis CDx test for this patient population and the ability
to identify patients likely to benefit from PARP inhibition
therapy; the number of patients with metastatic breast cancer who
would benefit from BRCA testing if approved as a new indication;
the Company’s ongoing collaboration with AstraZeneca to develop a
novel companion diagnostic test to identify candidates for
treatment with olaparib; and the Company's strategic directives
under the captions “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, 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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