Myriad Validates Active Surveillance Threshold With Prolaris(R) for Men With Prostate Cancer
May 15 2015 - 07:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today presented clinical data
for its Prolaris test at the 2015 American Urological Association
(AUA) Annual Meeting being held May 15 to 19 in New Orleans, La.
The results highlighted and underscored the significant ability of
the Prolaris test to help physicians improve care for men diagnosed
with prostate cancer.
In this pioneering study, Myriad presented important new
clinical validation data that establishes an active surveillance
(AS) threshold for men with localized prostate cancer.
Specifically, the AS threshold is a composite of the Prolaris test
score and clinicopathologic features. In the validation data
featured at AUA, the pre-defined AS threshold was evaluated in 765
conservatively managed men, and the clinical endpoint was 10-year
risk of prostate cancer mortality. The results showed that at the
AS threshold, the predicted 10-year survival rate of prostate
cancer patients was 97 percent. Conversely, there was a three
percent risk of 10-year, prostate-specific
mortality. Importantly, however, there were no observed
prostate cancer-specific deaths over 10 years among men whose
scores fell below the AS threshold.
Additionally, a separate analysis of 4,218 patients was
performed to determine what percentage of patients who were
clinically tested with Prolaris would be candidates for active
surveillance based on the validated AS threshold. Of this
commercial cohort, 36 percent qualified for active surveillance
based on their clinical features alone. However, when the
Prolaris test was added to the clinical risk assessment, 60 percent
of these patients fell below the AS threshold, representing a
significant increase in the total number of candidates who may be
eligible for active surveillance.
Table 1: Analysis of Commercial Cohort
(N=4,218)
|
Clinical Features
Alone |
Prolaris + Clinical
Features "AS Threshold" |
% Increase |
Number of Men Eligible for AS |
n=1,518 (36 percent) |
n=2,530 (60 percent) |
n=1,012 (24 percent) |
"Active surveillance is an important treatment option for men
with prostate cancer. The Prolaris active surveillance
threshold represents a significant change in the treatment of
prostate cancer because it provides valuable mortality prognostic
information at the time of diagnosis," said Michael Brawer, M.D.,
vice president of Medical Affairs, Myriad Genetic Laboratories.
"Men whose combined Prolaris Scores and clinicopathologic features
fall below the AS threshold can have confidence that active
surveillance is an appropriate option for them instead of surgery,
radiation or chemotherapy."
PROCEDE 1000 Final Analysis
In a podium presentation, Neal Shore, M.D., medical director at
Carolina Urologic Research Center, presented the final results from
PROCEDE 1000, the largest prospective clinical utility study to
measure the impact of the Prolaris test on the treatment of men
with localized prostate cancer. The analysis of 1,206 patients
demonstrated that physicians changed their treatment plans in 48
percent of cases after receiving the Prolaris test results. Of
these changes, 72.1 percent were reductions in treatment, and 26.9
percent were increases in treatment.
"We are very impressed by these real-world data. Prolaris
does what it is designed to do: help physicians determine the
aggressiveness of prostate cancer and thus personalize treatment
plans for their patients based upon that information," said Dr.
Shore. "Men with a high Prolaris Score, who are at high risk
of disease-specific mortality or recurrence, are receiving more
aggressive treatment, which should help save more
lives. Meanwhile, more patients with a low Prolaris Score are
receiving active surveillance, which spares them from the side
effects frequently associated with more aggressive treatments."
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly
measures tumor cell growth characteristics for stratifying the risk
of disease-specific mortality in prostate cancer patients. Prolaris
provides a quantitative measure of the RNA expression levels of
genes involved in the progression of tumor growth. Low gene
expression is associated with a low risk of disease-specific
mortality in men who may be candidates for active surveillance and
high gene expression is associated with a higher risk of
disease-specific mortality in patients who may benefit from
additional therapy. For more information, see our digital media kit
at www.myriad.com/media-kit/aua15 or visit: www.prolaris.com.
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 is
focused on strategic initiatives to grow existing markets,
diversify through the introduction of new products, including
companion diagnostics, and expand internationally. 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 Lung
Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris 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 presentation of new
clinical data on Prolaris at the AUA 2015 meeting; the ability of
the Prolaris test to help physicians improve care for men diagnosed
with localized prostate cancer; the ability of Prolaris to set a
new standard of care for prognostic genetic testing in men with
localized prostate cancer; 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 or will not
continue to increase at historical rates; risks related to our
ability to transition from our existing to new testing services,
including unexpected costs and delays; risks related to decisions
or 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 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; 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 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 in our most recent Annual Report on Form 10-K for the
fiscal year ended June 30, 2014, 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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