REDWOOD CITY, Calif.,
June 2, 2017 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today announced the presentation of
eight studies that provide additional evidence of the value of
Oncotype DX® tests in predicting clinically meaningful
endpoints and outcomes across multiple cancer types. The data from
patients with invasive breast, ductal carcinoma in situ (DCIS),
prostate and kidney cancers were presented in oral and poster
sessions at the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago.
"As part of our mission to make precision medicine available to
patients worldwide, we continue to conduct rigorous clinical
validation and utility studies to ensure that our Oncotype DX tests
provide reliable and actionable results," said Phil Febbo,
M.D., chief medical officer, Genomic Health. "The data
presented at ASCO 2017 continue to highlight the value of the
Oncotype DX Breast Recurrence Score, the Oncotype DX Breast DCIS
Score and the Oncotype DX Genomic Prostate Score tests in helping
physicians individualize care across patient populations to improve
treatment outcomes."
Large Outcomes Studies Continue to Confirm Prognostic Value
of the Oncotype DX Breast Recurrence Score®
Test
Multiple large prospective outcomes studies conducted by leading
international study groups have previously provided evidence from
real-world clinical practice in more than 63,000 invasive breast
cancer patients that the Oncotype DX Breast Recurrence Score test
consistently and accurately predicts the risk of distant recurrence
and chemotherapy benefit. Additional analyses from three of these
studies presented at ASCO 2017 continue to confirm the unique value
of the Oncotype DX test:
- An analysis of more than 49,000 patients in the Surveillance,
Epidemiology, and End Results (SEER) Registry program of the
National Cancer Institute (NCI) found that, in those with a
Recurrence Score® (RS) <18, reported chemotherapy use
was uncommon (3-8 percent) and the five-year breast cancer-specific
survival (BCSS) rate was high (>99 percent). In the group with
RS results 18-25, chemotherapy was administered more often (29
percent) and five-year BCSS was 99 percent regardless of
chemotherapy use (in both the chemotherapy-treated and the
non-chemotherapy-treated patients). (Abstract #537)
- A separate analysis of the SEER Registries evaluated the
relationship between the RS result and breast cancer-specific
mortality (BCSM) in 6,075 patients with lobular tumors. Five-year
BCSM was excellent in patients with a RS <25 and increased with
a RS >25. In a multivariable analysis, RS results, grade, tumor
size and age significantly predicted BCSM (p <0.001). (Abstract
#11568)
"These data show that the 21-gene Recurrence Score captures the
spectrum of risk in ER-positive breast cancer," said Harold J. Burstein, M.D., Ph.D., Dana-Farber
Cancer Institute and Harvard Medical
School. "Additionally, the SEER experience proves that
oncologists across the country can readily interpret these scores
to make good treatment decisions with their patients."
- Results of chemotherapy treatment from the prospective West
German Study Group's PlanB study, one of the largest contemporary
adjuvant breast cancer trials in Europe, were presented in an oral session.
Findings for the group of HER2-negative, early-stage breast cancer
patients with high clinical risk and RS results (>11) showed a
similar five-year disease-free survival for chemotherapy regimens
with and without an anthracycline, indicating that avoiding an
anthracycline may be an important option. In addition, the PlanB RS
results were consistent with previous chemotherapy trials
(NSABP-B28, PACS-01) showing the strong prognostic impact of the
Breast Recurrence Score test in chemotherapy-treated patients.
Previously presented findings from PlanB demonstrated that in women
with low RS results treated with hormonal therapy alone, five-year
disease-free survival was 94 percent. (Abstract #504)
- New data show that using the Oncotype DX Breast Recurrence
Score test to identify the right patients to treat with
chemotherapy can benefit patients 70 years of age or older, similar
to outcomes reported for younger patients. In the study, from
Clalit Health Services in Israel,
medical records of 458 elderly and 2,052 younger patients were
examined. Using patients' RS results, the researchers compared
given treatment and subsequent outcomes. The findings showed a
similar distribution of RS results between the age groups, that the
RS predicted recurrence risk, and that within each RS result group
(low, intermediate and high) there was no statistically significant
difference in clinical outcomes between older and younger patients.
(Abstract #543)
Additional Prostate Cancer Validation Studies Confirm Men
with Oncotype DX Genomic Prostate Score™ Results Below 20 Should be
Considered for Active Surveillance
The Oncotype DX Genomic Prostate Score (GPS) test was recently
validated to predict long-term outcomes, including metastasis and
prostate cancer death, in a cohort of men with clinically localized
disease in a large community-based, multi-center clinical
validation study conducted at Kaiser Permanente.
- At ASCO, additional data confirmed that patients with a GPS
result <20 and very low-, low- or intermediate-risk prostate
cancer are at very low risk of developing metastatic disease or
dying from prostate cancer in the 10-year period following radical
prostatectomy. Specifically, in an analysis of two large cohorts of
patients with low- or intermediate-risk prostate cancer (n=828),
only one man with a GPS result <20 died of prostate cancer.
(Abstract #5074)
"The latest validation of the Oncotype DX GPS test to predict
the risk of prostate cancer-specific death and metastasis, in
addition to adverse pathology, along with new data revealing very
favorable outcomes in patients with GPS results less than 20, will
assuredly enhance the ability of urologists and their low-risk
patients to fully understand the patient's newly diagnosed prostate
cancer. Then, through shared decision making, they will be able to
better decide whether active surveillance is right for them," said
Neal D. Shore, M.D., FACS, medical
director, Carolina Urologic Research Center and president, LUGPA.
"These results suggest that the GPS test can detect a subset of men
with particularly favorable long-term prognosis who should be very
good candidates for active surveillance and thus can safely avoid
an interventional treatment with potential associated morbidities
and costs."
- A separate study of 134 men with low- or intermediate-risk
prostate cancer who were treated with radical prostatectomy showed
that the GPS result was significantly associated with adverse
pathology and provided prognostic information independent of and
complementary to multiparametric MRI-guided biopsies. These
findings suggest that the information provided by the GPS test is
distinct from what may be determined from MRI, and that molecular
testing may improve management selection and patient outcomes for
men with localized prostate cancer, supporting confident treatment
decision making. (Abstract #5063)
Oncotype DX Breast DCIS Score™ Test, Combined with Age and
Tumor Size, Helps Identify Women Who Have Very Low Risk of
Recurrence Following Breast-conserving Surgery Alone
A meta-analysis of data from two studies involving 773 DCIS
patients who had undergone breast-conserving surgery without
radiation found that the Oncotype DX Breast DCIS Score result, age,
tumor size and year of surgery provided independent prognostic
information on the 10-year risk of local recurrence. These findings
suggest that the addition of these clinical and pathologic factors
to the DCIS Score result can help physicians better determine the
risk of local recurrence and guide individual decision making for
DCIS patients. (Abstract #528)
Prospective Validation Study in Patients with Kidney
Cancer Confirm Prognostic Value of a 16-gene Signature Developed by
Genomic Health
A previously validated RT-PCR-based prognostic test for kidney
cancer was applied to samples from participants in the S-TRAC trial
of adjuvant sunitinib, demonstrating a strong association between
the test score and radiographic progression-free survival and
overall survival. In this study, the 16-gene score result predicted
recurrence and survival outcomes in patients being treated as well
as in those given placebo. The strongest results were observed in
the placebo arm, where patients with a high score had significantly
higher risk of recurrence and cancer-specific mortality, suggesting
that in future studies the test may help identify patients most
likely to have greatest benefit from emerging adjuvant therapies.
(Abstract #4508)
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®, 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™ predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. In prostate cancer, the Oncotype DX
Genomic Prostate Score™ predicts disease aggressiveness and further
clarifies the current and future risk of the cancer prior to
treatment intervention. With more than 750,000 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 by 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 big
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 more than 750,000 cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid- and tissue-based tests, including the
recently launched Oncotype SEQ® Liquid
Select™ 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. 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: our business model; the applicability of clinical
study results to actual outcomes; the impact of results from
clinical studies on market adoption of Oncotype DX tests;
unanticipated costs or delays in research and development efforts;
and other risks and uncertainties set forth in our filings with the
Securities and Exchange Commission, including our most recent
report on Form 10-Q for the quarter ended March 31, 2017. 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, DCIS Score, Oncotype SEQ, Liquid Select, Genomic
Prostate Score, 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.