myChoice HRD(TM) Test Identifies Breast Cancer Patients Likely to Respond to Platinum-Containing Therapies
December 10 2015 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that new
data will be presented demonstrating the role of the myChoice HRD
companion diagnostic in identifying patients with breast cancer who
are likely to respond to a platinum-containing therapy. The data
will be presented at the 2015 San Antonio Breast Cancer Symposium
(SABCS) in San Antonio, Texas.
"There is mounting clinical evidence demonstrating the ability
of myChoice HRD to identify patients who experience improved
outcomes when treated with platinum-containing therapy," said
Anne-Renee Hartman, M.D., vice president of clinical development,
Myriad Genetic Laboratories. "Our collaborators will present data
showing how this test might be useful to optimize therapy selection
for patients. The data underscore the critical importance of
identifying patients at the time of diagnosis who are likely to
benefit from a therapeutic response to platinum prior to surgery.
These findings support earlier studies showing that myChoice HRD
gives the most complete picture of clinical response to
platinum-containing chemotherapy."
Details about the featured myChoice HRD presentations at SABCS
are below. Follow Myriad on Twitter via @MyriadGenetics and stay
informed about symposium news and updates by using the hashtag
#SABCS15.
myChoice HRD Presentations
Title: Homologous recombination deficiency
(HRD) as a predictive biomarker of response to neoadjuvant
platinum-based therapy in patients with triple negative breast
cancer (TNBC); A pooled analysis. Date: Thursday,
Dec.10, 2015: 5:00 to 7:00 p.m. CT. Location:
Poster P3-07-12. Presenter: Dr. Melinda Telli,
Stanford University Cancer Center.
A pooled analysis of five Phase II trials that included patients
with TNBC treated with neoadjuvant platinum-based chemotherapy was
conducted to evaluate the pathologic complete response (pCR) rates
in homologous recombination (HR) deficient and HR non-deficient
tumors. HR deficiency status was defined as either a positive
myChoice HRD score (42 or higher) or presence of a BRCA1/2 tumor
mutation (tBRCA). The results of this analysis with 267 patients
showed that myChoice HRD predicted pCR in TNBC across several
different platinum-based chemotherapy regimens. Specifically,
patients with a positive myChoice HRD score had a five-fold
increase in pCR compared to those with negative score.
Title: Homologous recombination deficiency
(HRD) as a predictive biomarker of response to preoperative
systemic therapy (PST) in TBCRC008 comprising a platinum in
HER2-negative primary operable breast cancer.
Date: Thursday, Dec.10, 2015: 5:00 to 7:00 p.m.
CT. Location: Poster P3-07-13.
Presenter: Dr. Roisin Connolly, Johns Hopkins
School of Medicine.
This study assessed the ability of myChoice HRD to predict
pathological complete response (pCR) in 48 patients with
ER-positive or triple negative breast cancer who were treated with
PST comprising a platinum drug. In the analysis of all
patients, the results showed a significantly higher pCR rate in
patients with a positive myChoice HRD score than a negative score
(50 percent vs 8 percent, p=0.002). A similar trend was observed
for both ER-positive and TNBC patients. In a subgroup analysis
of patients without a tBRCA mutation (n=40), there was a
significantly higher pCR rate in patients with a positive myChoice
HRD score than a negative score (64 percent vs 8 percent, p≤0.001).
These results show that myChoice HRD predicts response to a
platinum-containing chemotherapy regimen in the estimated 15
percent of newly diagnosed breast cancer patients with TNBC.
Furthermore, this is the first study to show that myChoice HRD may
be useful in predicting response to platinum-containing
chemotherapy regimens in patients with ER-positive, Her2-negative
breast cancer, which represents approximately 70 percent of newly
diagnosed breast cancer patients.
For more information about these presentations, please visit the
SABCS website at https://www.sabcs.org/.
About myChoice HRD™
Myriad's myChoice HRD is the first homologous recombination
deficiency test that can 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. High 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 1.8 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, 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 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 likelihood of patients
with a positive myChoice HRD™ score to be five times more likely to
respond to platinum-containing therapies; the usefulness of the
myChoice HRD test to optimize therapy selection for patients; the
myChoice HRD test giving the most complete picture of clinical
response to platinum-containing chemotherapy; and the Company's
strategic directives under the caption "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
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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
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our molecular diagnostic tests and pharmaceutical and clinical
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Item 1A of our most recent Annual Report on Form 10-K for the
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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
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CONTACT: Media Contact: Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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