Additional Detail in Patients Age 50 or Younger Presented
Today in Oral Session at 2019 American Society of Clinical
Oncology (ASCO) Annual Meeting
TAILORx Continues to Elevate Oncotype DX® to a New
Global Standard with Increasing Utilization and
Reimbursement
REDWOOD CITY, Calif.,
June 3, 2019 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today
announced that results from a new analysis of the Trial Assigning
IndividuaLized Options for Treatment (Rx), or TAILORx, confirm the
original, definitive conclusions reported last year with additional
detail on clinical risk, focusing on patients with early-stage
breast cancer who are age 50 years or younger. These findings,
published today in The New England Journal of Medicine and
presented at the 2019 American Society of Clinical Oncology (ASCO)
Annual Meeting, showed that stratifying patients by clinical risk
(tumor size and histologic grade) alone does not predict
chemotherapy benefit. Clinical risk provides prognostic information
that is complementary to the Oncotype DX Breast Recurrence
Score® test and may help identify younger women who
benefit from more effective therapy.
"We're pleased to see leading authorities, including The
New England Journal of Medicine and ASCO, continue to
recognize the significant results and impact of TAILORx one year
after it established that Oncotype DX definitively identifies the
vast majority of women with early-stage breast cancer who receive
no benefit from chemotherapy, and the important minority for whom
chemotherapy can be life-saving," said Steven Shak, M.D.,
chief scientific officer, Genomic Health. "The additional insight
from this new analysis confirms young women with breast cancer are
not all the same and indicates that they should be treated
individually based on the biology of their disease, as determined
by Oncotype DX and an assessment of their clinical risk."
A secondary objective of TAILORx, the largest ever breast cancer
treatment trial, sponsored by the National Cancer Institute (NCI),
and led by the ECOG-ACRIN Cancer Research Group, was to evaluate
whether clinical risk provides additional prognostic or predictive
information to the Recurrence Score (RS) results. Of 9,427 women in
TAILORx with a RS and clinical risk information, 70 percent were
determined to be low clinical risk (tumor ≤3 cm and low grade, ≤2
cm and intermediate grade, or ≤1 cm and high grade) and 30 percent
were identified as high clinical risk (not meeting low clinical
risk criteria). While clinical risk provided additional prognostic
information across all RS groups, disease-free survival and distant
recurrence-free interval rates were similar with and without
chemotherapy in the entire RS 11-25 group irrespective of clinical
risk.
"Last year, TAILORx established the highest level of evidence
and unprecedented precision supporting use of the Oncotype DX
Breast Recurrence Score to guide adjuvant chemotherapy treatment
for women with early-stage breast cancer," said lead author
Joseph A. Sparano, M.D., associate
director for clinical research at the Albert Einstein Cancer Center
and Montefiore Health System in New
York, and vice chair of the ECOG-ACRIN Cancer Research
Group. "With this new analysis, it is clear that women age 50 or
younger with a Recurrence Score result between 16 and 20 and low
clinical risk do not need chemotherapy. Furthermore, Oncotype DX in
combination with clinical risk factors could identify premenopausal
women with higher clinical risk who may benefit from ovarian
function suppression and more aggressive anti-estrogen
therapy."
The groundbreaking TAILORx results, presented during the Plenary
Session at the 2018 ASCO Annual Meeting and simultaneously
published in The New England Journal of
Medicine, are elevating Oncotype DX to a new global
standard of care with increasing, and more consistent, use of
Oncotype DX by physicians worldwide for all medically eligible
patients. Additionally, important guidelines globally distinguish
Oncotype DX from other prognostic-only tests based on clinical
evidence and the critical importance of predicting chemotherapy
benefit. This includes the recent update to ASCO guidelines, which
increased the proportion of women who can be effectively treated
without chemotherapy based on the strong and highest level of
evidence from TAILORx, as well as National Comprehensive Cancer
Network (NCCN) guidelines, which were updated last fall to
categorize Oncotype DX as the only "preferred" test for
chemotherapy treatment decision-making for patients with
node-negative early-stage breast cancer. The landmark TAILORx study
is also having an important impact on global reimbursement of
Oncotype DX, including in Germany.
Following the German Institute for Quality and Efficiency in Health
Care's (IQWiG's) positive assessment, the German Federal Joint
Committee (G-BA) is expected to make a decision on Oncotype DX
reimbursement at its plenary meeting on June
20.
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 Recurrence
Score® test, is the only test that has been shown to
predict the likelihood of chemotherapy benefit as well as
recurrence in invasive breast cancer. Additionally, the Oncotype DX
Breast DCIS Score test predicts the likelihood of recurrence in a
pre-invasive form of breast cancer called DCIS. In prostate cancer,
the Oncotype DX Genomic Prostate Score® test predicts
disease aggressiveness and further clarifies the current and future
risk of the cancer prior to treatment intervention, and the
Oncotype DX AR-V7 Nucleus Detect™ test helps determine
which patients with metastatic castration-resistant prostate cancer
(mCRPC) are resistant to androgen receptor (AR)-targeted therapies.
The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic
Sciences at its centralized, CLIA-certified laboratory in
San Diego and offered exclusively
by Genomic Health. With more than 1 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 tests,
visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatment.org.
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that help optimize cancer care, including
addressing the overtreatment of the disease, one of the greatest
issues in healthcare today. With its Oncotype
IQ® Genomic Intelligence Platform, the company is
applying its world-class scientific and commercial expertise and
infrastructure to lead the translation of clinical and genomic data
into actionable results for treatment planning throughout the
cancer patient journey, from diagnosis to treatment selection and
monitoring. The Oncotype IQ portfolio of genomic tests and services
currently consists of the company's flagship line of Oncotype
DX® gene expression tests that have been used to guide
treatment decisions for over 1 million cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid- and tissue-based tests, including the
Oncotype DX® AR-V7 Nucleus
Detect™ test. 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 Oncotype
DX Breast Recurrence Score test to physicians, patients and payors;
the results of the TAILORx study including secondary analysis and
its implications on clinical treatment decisions; the ability of
the Oncotype DX Breast Recurrence Score test to improve patient
outcomes; and the ability of the company to achieve additional
global reimbursement coverage for its Oncotype DX Breast Recurrence
Score test, including in Germany.
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 results of clinical studies; the applicability of
clinical study results to actual outcomes; the ability of the test
results to change treatment decisions and improve patient outcomes;
the risks and uncertainties associated with the regulation of the
company's tests; 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 annual report filed
on Form 10-Q for the year ended March 31,
2019. 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, Breast
Recurrence Score, DCIS Score, Genomic Prostate Score, GPS, Oncotype
DX AR-V7 Nucleus Detect, and Oncotype IQ are trademarks or
registered trademarks of Genomic Health, Inc. All other trademarks
and service marks are the property of their respective
owners.
GHDX-B
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SOURCE Genomic Health, Inc.