Myriad Presents Data on BRACAnalysis CDx(TM) and HRD(TM) at 2014 ASCO Meeting
May 30 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN), a global leader in molecular
diagnostics, announced the presentation of new data at the American
Society of Clinical Oncology (ASCO) meeting this week that supports
the clinical efficacy of its BRACAnalysis CDx™ and HRD™ tests in
predicting platinum based therapy response for breast cancer
patients. Additionally, the company is providing an update on key
commercial milestones that underscore its commitment to the field
of companion diagnostics.
"Myriad is committed to advancing the science of companion
diagnostics and is currently working with approximately 20
different pharmaceutical companies on companion diagnostic
programs," said Mark Capone, president of Myriad Genetic
Laboratories. "We believe the future of pharmaceuticals depends on
providing therapeutics to patients that are tailored to their
individual genetic makeup, and we are investing substantial
resources to maintain our global leadership position in this
field."
Data on BRACAnalysis CDx in Metastatic Breast Cancer
Patients
At this week's ASCO meeting, Myriad will present data supporting
BRACAnalysis CDx's ability to predict platinum response in
metastatic breast cancer patients. In a trial of 86 patients, the
response rates to platinum based therapies (carboplatin and
cisplatin) for patients with deleterious mutations detected by
BRACAnalysis CDx (the Company's proprietary companion diagnostic
test for deleterious mutations and large rearrangements in the
BRCA1 and BRCA2 genes) was 54.5 percent compared to only 19.7
percent in the non-carrier group. These data underscore the ability
of BRACAnalysis CDx to predict patient response to platinum based
therapies in a patient population characterized by low overall
response rates.
Myriad is making substantial progress toward the
commercialization of BRACAnalysis CDx for PARP inhibitors and
several of Myriad's commercial pharmaceutical partners have
recently made major announcements on the advancement and expansion
of their PARP inhibitor programs. Below is a table summarizing the
announced, late-stage clinical trials by commercial partners in
which Myriad is providing the companion diagnostic test in support
of the drug.
|
|
|
|
|
Company |
Drug |
Clinical Trial
Phase/Indications |
Timeline |
Myriad Test |
AstraZeneca |
olaparib |
Phase 3 – platinum sensitive relapsed ovarian
cancer |
Expect U.S. FDA and EMA approval for platinum
sensitive ovarian cancer in |
BRACAnalysis CDx™ |
|
|
Phase 3 – first line maintenance therapy
for ovarian cancer |
CY15. Expect to file with the FDA for breast
cancer in CY16. |
|
|
|
Phase 3 – metastatic breast cancer |
|
|
|
|
Phase 3 – neoadjuvant breast cancer |
|
|
|
|
Phase 3 – adjuvant breast cancer |
|
|
Biomarin |
BMN-673 |
Phase 3 – metastatic breast cancer |
NA |
BRACAnalysis CDx™ |
AbbVie |
veliparib |
Phase 3 – neoadjuvant treatment of
triple negative breast cancer |
NA |
BRACAnalysis CDx™ |
Tesaro |
niraparib |
Phase 3 – platinum sensitive ovarian
cancer |
NA |
BRACAnalysis CDx™ |
|
|
Phase 3 – metastatic breast cancer |
|
|
"In the area of cancer, we are seeing significant progress by
our pharmaceutical partners in the advancement of PARP inhibitors
toward commercialization in a variety of cancer types and we are
excited to be providing best-in-class diagnostics in support of
these important therapeutics," said Capone. "Myriad is uniquely
positioned as a global diagnostic company to provide these highly
complex tests with the accuracy and turnaround times required to
have a positive impact on patient care."
New Data on Myriad's Proprietary HRD Test Supports
Planned Commercial Launch in FY15
Myriad also will present data looking at the ability of the
Company's proprietary HRD tumor test in terms of its ability to
predict response among triple negative breast cancer patients. The
combination of Myriad's three HRD assays including Loss of
Heterogyzosity (LOH), Telomere Allelic Imbalance (TAI), and
Large-Scale State Transition (LST) were highly correlated with
patient response rates. These data further highlight the likely
utility of HRD as a more comprehensive companion diagnostic for DNA
damaging agents.
In addition, Myriad announced a new 160 patient randomized study
evaluating HRD as a biomarker for prediction of cisplatin and
paclitaxel response in triple negative breast cancer patients at
diagnosis. This is one of several ongoing clinical trials Myriad is
conducting looking at the predictive power of HRD in guiding
platinum based therapy. Myriad plans to present data later this
year on HRD that will support an early access launch of the test in
triple negative breast cancer patients in late fiscal year
2015.
"High HRD scores have been shown in early research to be highly
correlated with response rates to DNA damaging agents such as
platinum based therapies," said Jerry Lanchbury, chief scientific
officer at Myriad Genetics. "We believe that, with further
validation, the HRD test has the potential to become the gold
standard diagnostic to identify patients who have lost DNA repair
function and are most suitable for this class of
therapeutics."
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions and
assess risk of disease progression and recurrence. Myriad's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, BRACAnalysis CDx, HRD, Prolaris, Myriad
myPath, Myriad myPlan and Myriad myRisk are trademarks or
registered trademarks of Myriad Genetics, Inc. 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 relating to the clinical efficacy of the
Company's HRD and BRACAnalysis CDx assays in predicting therapy
response for cancer patients; the Company's commitment to advancing
the science of companion diagnostics and work with multiple
pharmaceutical companies on companion diagnostic programs; the
Company's belief that the future of pharmaceuticals depends on
providing therapeutics to patients that are tailored to their
individual genetic makeup, and the Company's investment of
substantial resources to maintain our global leadership position in
this field; the significant clinical utility of the BRACAnalysis
CDx test at predicting response rates to platinum based therapies;
the ability of the HRD test to predict response among triple
negative breast cancer patients and its utility as a more
comprehensive companion diagnostic for DNA damaging agents; the
Company's plan for an early access launch of the HRD test in triple
negative breast cancer patients in late fiscal year 2015; the
Company's belief that with further validation the HRD test has the
potential to become the gold standard diagnostic to identify
patients who have lost DNA repair function and are most suitable
for this class of therapeutics; the statements and information
under the caption "Progress With Commercial Partners on PARP
Inhibitors;" and the Company's strategic directives under the
caption "About Myriad Genetics." These "forward-looking statements"
are management's present 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
described in the forward-looking statements. These risks include,
but are not limited to: the risk that sales and profit margins of
our existing molecular diagnostic tests and companion diagnostic
services may decline or will not continue to increase at historical
rates; risks related to changes in the governmental or private
insurers reimbursement levels for our tests; the risk that we may
be unable to develop or achieve commercial success for additional
molecular diagnostic tests and companion diagnostic services in a
timely manner, or at all; the risk that we may not successfully
develop new markets for our molecular diagnostic tests and
companion diagnostic 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 companion diagnostic services tests and any future tests
are terminated or cannot be maintained on satisfactory terms; risks
related to delays or other problems with operating our laboratory
testing facilities; risks related to public concern over our
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 increased competition and the
development of new competing tests 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; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and companion
diagnostic 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 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Apr 2023 to Apr 2024