Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced new results
from two studies with EndoPredict
® are being
featured at the 2017 San Antonio Breast Cancer Symposium (SABCS) in
San Antonio, Texas. EndoPredict is a second-generation
prognostic gene expression test for patients with breast cancer.“We
are excited to present new data on our EndoPredict test which
demonstrates our ongoing commitment to collaborate with leading
academic research centers and advance personalized medicine for
patients with breast cancer,” said Ralf Kronenwett, M.D., Ph.D.,
director of International Medical Affairs, Myriad Genetics.
“Importantly, these new studies add to the expanding body of
evidence demonstrating how EndoPredict can be used to predict both
disease recurrence as well as response to therapy.”The data are
highlighted below and abstracts are available at:
https://www.sabcs.org/2017-SABCS. Follow Myriad on Twitter
via @MyriadGenetics and stay informed about symposium news and
updates by using the hashtag #SABCS17.
EndoPredict Podium Presentation
Title: The EndoPredict score predicts
residual cancer burden to neoadjuvant chemotherapy and to
neuroendocrine therapy in HR+/HER2- breast cancer patients from
ABCSG34.Presenter: Peter Dubsky, M.D.,
Medical University of Vienna, Austria and the Breast Center St.
Anna Klinik, Lucerne.Date: Friday, Dec. 8,
2017, 3:15–5:00 p.m. Location: Podium,
GS6-04
This study was designed to show the predictive value of the
EndoPredict (EP) 12-gene molecular score for tumor response to
neoadjuvant chemotherapy and neoendocrine therapy. The study
included biopsies from 217 women with HR+ breast cancer. Of
these, 134 patients were assigned to receive neoadjuvant
chemotherapy according to aggressive clinico-pathologic tumor
features. The remaining 83 patients were clinically
identified as having luminal A types of breast cancer and were
assigned to receive neoendocrine treatment. The primary
endpoint was residual cancer burden RCB0/I (i.e., good tumor
response) vs. RCB II/III (i.e., poor tumor response) at time of
surgery.In the neoadjuvant chemotherapy group, 125 patients had
high EP scores and nine had a low EP score. The results show
that 26.4 percent of those with a high score showed a good tumor
response (RCB0/I) to neoadjuvant chemotherapy, while all patients
with a low score showed only a poor tumor response (Table 1).
In the “luminal A” group receiving neoendocrine therapy, 39
patients had a high EP score and 44 had a low EP score. The
results show that 27.3 percent of those with a low EndoPredict
score and 7.7 percent with a high score achieved excellent tumor
response (RCB0/I) to neoendocrine therapy (Table 1).
|
|
|
|
Table. 1 |
EndoPredict Low
Score |
EndoPredict High
Score |
p-Value |
Response toNeoadjuvant Chemotherapy |
0.0 |
% |
26.4 |
% |
p=0.0001 |
Response toEndocrine Therapy |
27.3 |
% |
7.7 |
% |
P=0.015 |
|
|
|
|
|
|
“This exciting study is evidence that women with a high EP score
responded better to neoadjuvant chemotherapy than those with a low
score, while those with a low EndoPredict score responded better to
neoadjuvant endocrine therapy,” said Peter Dubsky, M.D., principal
investigator, speaking on behalf of the Austrian Breast and
Colorectal Cancer Study Group (ABCSG). “These findings are
relevant to better patient selection for biomarker driven studies
in the neoadjuvant setting.”
EndoPredict Poster Presentation
Title: The role of EndoPredict in invasive
lobular carcinoma.Presenter: Ivana Sestak,
Ph.D., Centre for Cancer Prevention, Wolfson Institute of
Preventive Medicine, Queen Mary University of London.
Date: Thursday, Dec. 7, 2017, 5:00–7:00 p.m.
Location: Poster, P3-08-01
This study evaluated the role of EndoPredict molecular-clinical
score (EPclin) for the prediction of distant recurrence in women
diagnosed with invasive lobular carcinoma (ILC) compared to those
with invasive ductal carcinoma (IDC). The study included 928
women with E R+/HER2- breast cancer: 141 had ILC, 710 had IDC and
77 were mixed type.This result shows that EndoPredict provided
significant power for predicting distant recurrence in patients
with both ILC (EPclin: LR-X2=5.8) and IDC (EPclin:
LR-X2=13.8). Women with ILC who had a high EPclin score were
at seven times increased risk of 10-year distant recurrence with
endocrine therapy only than patients with low EPclin score.
In comparison, women with IDC who had a high EPclin score were at
five times increased risk of 10-year recurrence than patients with
low EPclin score. Importantly, there was a similar 10-year
distant recurrence risk in patients with a low EPclin score (~6
percent), which suggests that chemotherapy is not indicated in
these patients with a low risk score regardless of tumor type.“Our
results show that EndoPredict provided highly significant
prognostic information and risk stratification in women with
invasive lobular carcinoma,” said Ivana Sestak, Ph.D., principal
investigator, Centre for Cancer Prevention, Wolfson Institute of
Preventive Medicine, Queen Mary University of London.
“Importantly, the 10-year risk of distant recurrence in the
EndoPredict low-risk groups was similar between ILC and IDC,
suggesting that chemotherapy is not indicated for these patients,
irrespective of tumor type.”
About EndoPredictEndoPredict is a
second-generation, multigene prognostic test for patients diagnosed
with breast cancer. The test provides physicians with
information to devise personalized treatment plans for their
patients. EndoPredict has been validated in approximately
4,000 patients with node-negative and node-positive cancer and has
been used clinically in more than 20,000 patients. In
contrast to first-generation multigene prognostic tests,
EndoPredict detects the likelihood of late metastases (i.e.,
metastasis formation after more than five years) and, therefore,
can guide treatment decisions regarding the need for chemotherapy,
as well as extended anti-hormonal therapy. Accordingly, therapy
decisions backed by EndoPredict confer a high level of diagnostic
safety. For more information, please visit:
www.endopredict.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
five strategic imperatives: stabilizing hereditary cancer
revenue, growing new product volume, expanding reimbursement
coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. 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, EndoPredict, Vectra, GeneSight,
riskScore 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 relating to the presentation of two new positive studies
for the EndoPredict Test at the 2017 San Antonio Breast Cancer
Symposium; the study results demonstrating that the EndoPredict
test accurately predicts response to neoadjuvant chemotherapy and
neoendocrine therapy in women with HR+ breast cancer; the ability
of EndoPredict to be used to predict both disease recurrence as
well as response to therapy; the study evidencing that women with a
high EP score responded better to neoadjuvant chemotherapy than
those with a low score, while those with a low EndoPredict score
responded better to neoadjuvant endocrine therapy; the relevance of
these findings to better patient selection for biomarker driven
studies in the neoadjuvant setting; 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 described or implied 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 pharmaceutical and clinical services
may decline or will not continue to increase at historical rates;
risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
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 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 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, including
but not limited to our acquisition of Assurex, Sividon and the
Clinic; risks related to our projections about the potential market
opportunity for our products; 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 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; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; and other
factors discussed under the heading “Risk Factors” contained in
Item 1A of our most recent Annual Report on Form 10-K, 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.
Media Contact:Ron Rogers(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott
Gleason(801) 584-1143sgleason@myriad.com
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