REDWOOD CITY, Calif.,
Sept. 28, 2015 /PRNewswire/ --
Genomic Health, Inc. (Nasdaq: GHDX) today announced that, in
addition to the positive five-year results from a group of patients
with low Oncotype DX® Recurrence Score® results from the watershed
ECOG-ACRIN Cancer Research Group's TAILORx (Trial
Assigning IndividuaLized Options for
Treatment [Rx]) study, sponsored by the National Cancer
Institute (NCI), published today in The New England
Journal of Medicine, two additional positive international
Oncotype® DX clinical outcomes studies were presented at the 2015
European Cancer Congress (ECC2015). Together, these new studies
establish Oncotype DX as the only genomic breast cancer test with
prospective outcomes data in more than 5,700 patients to date,
providing evidence that the biology information from the test
should be included in treatment decisions.
Reinforcing the published findings from TAILORx, two additional
Oncotype DX clinical outcomes studies included positive results
from a large, multi-center cohort from Clalit Health Services in
Israel with follow-up exceeding 5
years, and a separate study of prospective survival results from
the WSG Phase III Plan B trial in Germany.
"These studies from Israel and
Germany provide additional strong
evidence of the value of the test in guiding decision to treat with
chemotherapy in mid-range and high-risk patients, complementing the
findings of the TAILORx trial, which demonstrated that more than 99
percent of patients with low Oncotype DX Recurrence Score results
of 10 or less had no distant recurrence at five years after
treatment with hormonal therapy alone," said Steven Shak, M.D., chief scientific officer,
Genomic Health. "Collectively with the TAILORx trial results in the
low-risk cohort, the new data presented at ECC2015 provide the
highest level of clinical evidence demonstrating the
practice-changing impact of the Oncotype DX test on breast cancer
treatment worldwide."
Oncotype DX Recurrence Score Used to Select Treatment and
Optimize Outcomes
In an analysis of medical records of 930 patients across four
medical centers within Clalit Health Services, the largest Health
Maintenance Organization in Israel, Oncotype DX was used to identify
patients for treatment with hormonal therapy alone or with hormonal
therapy plus chemotherapy (abstract #1963). Women with low
Recurrence Score results less than 18 showed very low distant
recurrence rates (0.5 percent) after five years of
follow-up.
Women with high Recurrence Score results (greater than or equal
to 31) and intermediate Recurrence Score results (between 18 and
30) had a 4 percent and 2.3 percent risk of distant recurrence,
respectively, after five years of follow-up. The selection of
patients for chemotherapy treatment was consistent with the
Recurrence Score results as recommended in treatment
guidelines.
"Results from our registry suggest that adding molecular
information provided by the Oncotype DX test is essential in order
to spare low-risk patients the toxicity and side effects of
chemotherapy," said Prof. Salomon
Stemmer, lead investigator of the study, Department of
Oncology, Davidoff Center, Rabin Medical Center affiliated to
Tel Aviv University, Israel.
"Knowing that Oncotype DX is predictive of chemotherapy benefit
gave us confidence to move forward with appropriate, individualized
treatment for each patient."
An additional analysis from the prospective Plan B trial,
Europe's largest contemporary
adjuvant breast cancer trial conducted by the Women's Healthcare
Study Group in Germany, showed a
high level of discordance in tumor grade assessment as performed by
central and local pathologists (abstract #1937). The investigators
also reported that patients with a Recurrence Score result between
0 and 11 who were treated by hormonal therapy alone had excellent
three-year relapse-free survival.
Earlier today, initial results were announced from TAILORx, one
of the largest-ever adjuvant breast cancer trials, designed and
conducted by the ECOG-ACRIN Cancer Research Group and sponsored by
the National Cancer Institute (NCI), The study demonstrated that a
group of early-stage breast cancer patients with low Oncotype DX
Recurrence Score results of 10 or less who received hormonal
therapy alone without chemotherapy had less than a one percent
chance of distant recurrence at five years. The results of this
trial were published online today in The New England Journal of
Medicine. The data safety monitoring board of the trial, as
mandated by the study protocol, continues to monitor outcomes in
patients with a Recurrence Score of 11 to 25 randomized to
chemo-endocrine therapy or endocrine therapy alone.
About Oncotype DX®
The Oncotype
DX® portfolio of breast, colon and prostate cancer tests
applies advanced genomic science to reveal the unique biology of a
tumor in order to optimize cancer treatment decisions. The
company's flagship product, the Oncotype DX breast cancer test, has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
test predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. With half a million patients tested
in more than 90 countries, the Oncotype DX tests have redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about Oncotype DX breast
cancer tests, visit: www.OncotypeDX.com or
www.mybreastcancertreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ:
GHDX) is the world's leading provider of genomic-based diagnostic
tests that address both the overtreatment and optimal treatment of
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. The company is
based in Redwood City, California,
with international headquarters in Geneva, Switzerland. For more information,
please visit, www.GenomicHealth.com and follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the benefits of the test to
physicians, patients and payors. Forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially, and reported results should not be considered
as an indication of future performance. These risks and
uncertainties include, but are not limited to: the ability of test
results to change treatment decisions; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; and the other risks set forth in the
company's filings with the Securities and Exchange Commission,
including the risks set forth in the company's quarterly report on
Form 10-Q for the year ended June 30,
2015. These forward-looking statements speak only as of the
date hereof. Genomic Health disclaims any obligation to update
these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX,
Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks and service
marks are the property of their respective owners.
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SOURCE Genomic Health, Inc.