Prospective Study Demonstrates EndoPredict® Can Guide Chemotherapy Decision For Women with Early-Stage Breast Cancer
December 07 2018 - 8:32AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that academic researchers
from the Technical University of Munich (TUM) presented the first
prospective outcomes data on EndoPredict® at the San Antonio Breast
Cancer Symposium in San Antonio, Texas. One of the key
findings is that EndoPredict high-risk patients had a better
outcome with adjuvant chemotherapy compared to endocrine therapy
alone.“There is a critical need for improved test options that
optimally combine genetic information from the tumor with important
clinical features and help clinicians develop precision treatment
plans for women with breast cancer,” said Johannes Ettl, M.D., lead
investigator and head of the Gyneco-Oncological Outpatient Clinic,
TUM “We are excited to present the first-ever prospective outcome
data for the EndoPredict test which demonstrated the ability to
predict disease free survival and guide decision of adjuvant
chemotherapy use in hormone receptor positive, HER2-negative breast
cancer.”The key data being presented at SABCS are summarized
below.
Title: First prospective outcome data for the
clinic-molecular test EndoPredict in hormone receptor positive,
HER2-negative early breast cancer in clinical
routine.Presenter: Johannes Ettl, M.D., TUM.
Date: Friday, Dec. 7, 2018, 7:30-9:00
a.m.Poster: P4-08-11
This prospective study evaluated outcomes data
of patients whose adjuvant systemic chemotherapy recommendation was
based on the EndoPredict (EPclin) test result. All patients
were evaluated for treatment compliance, local recurrence, distant
metastases and survival. A total of 373 patients with HR+,
HER2- early breast cancer pts with 0-3 positive lymph nodes were
enrolled between March 2012 and March 2015. The EndoPredict
test allocated 238 pts (63.8 percent) in the low-risk group and 135
pts (36.2 percent) in the high-risk group. Of these, 128
patients were recommended to undergo adjuvant chemotherapy in
addition to endocrine therapy and 92 (72 percent) of patients were
compliant having received standard-of-care chemotherapy.
EndoPredict High vs. Low Risk ScoresThe results
show that the disease free survival (DFS) and distant metastases
free survival (DMFS) in the low-risk group was 96.6 percent and
99.6 percent compared to 94.9 percent and 97.6 percent in the
high-risk group. These results equate to a two-fold (HR 2.05;
p=0.110) higher risk of disease recurrence and a five-fold (HR
5.18; p=0.0443) higher risk of distant metastases in patients with
high EndoPredict scores vs low scores.
Demonstration of Chemotherapy BenefitThe
analysis also demonstrated that EndoPredict high-risk patients who
received adjuvant chemotherapy had a 3-year DFS of 96.3 percent
compared to 91.5 percent in those high-risk patients who did not
receive chemotherapy (HR: 0.32; p=0.06).
“In this first analysis of clinical data from our breast center,
patients who were classified as high risk by EndoPredict and who
received chemotherapy experienced a 68 percent reduction in relapse
compared to patients who did not receive the recommended
chemotherapy,” said Prof. Marion Kiechle, M.D., director of the
Women´s Hospital, TUM. “After a median follow up of 3.5
years, the results approached statistical significance
(p=0.06). For the first time, we looked at prospective data
which demonstrated that EndoPredict has the capacity to predict
chemotherapy benefit in EPclin high-risk patients. Future
analyses with longer follow up will shed further light on this
chemopredictive ability of the EndoPredict test.”
About Breast CancerOne in eight American women
will have breast cancer during her lifetime. Breast cancer is the
second leading cause of cancer death among American women.
The American Cancer Society estimates in its Cancer Facts
& Figures 2018 report that more than 250,000 women will be
told they have breast cancer in 2018.
About EndoPredict®EndoPredict is a
second-generation, multigene prognostic test that aids personalized
treatment planning for patients with early-stage breast
cancer. EndoPredict has been validated in approximately 4,000
patients with node-negative and node-positive disease and has been
used clinically in more than 25,000 patients. In contrast to
first-generation multigene prognostic tests, EndoPredict is
validated to accurately predict both early (0-5) and late (5-15
years) distant recurrence and for prediction of benefit from both
adjuvant chemotherapy as well as which patients can safely forgo
extended endocrine therapy beyond five years. EndoPredict is
manufactured by Myriad Genetics, Inc.
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 critical success
factors: build upon a solid hereditary cancer foundation,
grow new product volume, expand reimbursement coverage for new
products, increase RNA kit revenue internationally and improve
profitability with Elevate 2020. 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, Prolaris, ForeSight and Prelude 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.Oncotype Dx is a registered trademark of Genomic Health,
Inc.
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 presentation of prospective outcome data
for the EndoPredict test, demonstrating the ability to predict
disease free survival and guide decision of adjuvant chemotherapy
use; 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
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; 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 for the fiscal year ended June 30, 2018, 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
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason(801)
584-1143sgleason@myriad.com
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