Genomic Health Announces Positive Results from Large Study of Oncotype DX® to
Quantify Risk of Loco-Regional Recurrence in Node-positive Breast Cancer
Patients and Acceptance of Oncotype DX DCIS Validation Study for Publication
Findings suggest value of Oncotype DX in tailoring radiation therapy treatment
for select node-positive patients treated with hormonal therapy and
Oncotype DX DCIS validation study accepted by peer-reviewed journal for
publication in coming months
REDWOOD CITY, Calif., March 13, 2013
REDWOOD CITY, Calif., March 13, 2013 /PRNewswire/ --Genomic Health, Inc.
(Nasdaq: GHDX) today announced positive results of a large study that
demonstrates the Oncotype DX® Recurrence Score® result to be a robust
predictor of loco-regional recurrence (LRR) in node-positive (N+), estrogen
receptor (ER) positive patients treated with adjuvant hormonal therapy and
chemotherapy. This study, titled "Prognostic impact of the 21-gene Recurrence
Score (RS) on loco-regional recurrence (LRR) of node-positive, ER-positive
breast cancer patients (pts) treated with adjuvantchemotherapy: Results from
NSABPB-28" was recently presented at the 2013 Society of Surgical Oncology
Annual Cancer Symposium in National Harbor, Maryland.
"Gaining a better understanding of the patient's individual risk of
loco-regional recurrence can assist physicians in determining the most
appropriate comprehensive treatment plan," said Terry Mamounas, M.D., Medical
Director, Comprehensive Breast Program, MD Anderson Cancer Center Orlando,
and member of the National Surgical Adjuvant Breast and Bowel Project (NSABP)
board. "These new data show that for ER-positive lymph node-positive breast
cancer patients, Oncotype DX not only helps identify those who will have
excellent outcomes with adjuvant chemo-endocrine therapy, as previously
reported, but it can also be useful for radiation treatment decision making."
This study analyzed tumor samples from 1,065 hormone receptor-positive,
node-positive breast cancer patients who were treated with hormonal therapy
and anthracycline containing chemotherapy as part of the NSABP B-28 trial.
After a median follow-up of 11.2 years, 80 patients had local (68 percent) or
regional (32 percent) recurrence. The 10-year cumulative incidence of
loco-regional recurrence was 3.3 percent for patients with a low Recurrence
Score result, 7.2 percent for those with an intermediate Recurrence Score
result, and 12.3 percent for those with high Recurrence Score result
(p<0.001), demonstrating that the Recurrence Score was significantly
associated with the risk of loco-regional recurrence. These new findings may
have clinical implications in node-positive patients treated with adjuvant
chemo-endocrine therapy as they consider post-mastectomy chest wall or
regional nodal radiotherapy, and post-lumpectomy regional nodal radiotherapy.
"Previous studieshave shownthe value of Oncotype DX in predicting
chemotherapy benefit in both node-negative and node-positive breast cancer.
Based on the results presented by Dr. Mamounas, we now have evidence
suggesting the value of the Oncotype DX result in tailoring the intensity and
extent of radiation in breast cancer patients with node-positive disease,"
said Steven Shak, M.D., chief medical officer and executive vice president for
research and development at Genomic Health. "This study, combined with an
upcoming publication in DCIS, demonstrates our continued efforts in helping
physicians and breast cancer patients answer important treatment decision
questions about the intensity of their radiation therapy."
The parent NSABP B-28 trial was funded by the National Cancer Institute with
additional support from Bristol Myers Squibb. The study evaluating the
prognostic impact of the 21-gene Recurrence Score on loco-regional recurrence
was funded through a grant from the Susan G. Komen for the Cure Foundation.
Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that
provides actionable genomic information to personalize cancer treatment
decisions. The company's lead 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 and has been shown to predict the
likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to
this widely adopted test, Genomic Health provides the Oncotype DX colon cancer
test, the first multi-gene expression test developed for the assessment of
risk of recurrence in patients with stage II and stage III disease. As of
December 31, 2012, more than 10,000 physicians in over 70 countries had
ordered approximately 335,000 Oncotype DX tests. Genomic Health has a robust
pipeline focused on developing tests to optimize the treatment of prostate and
renal cell cancers, as well as additional treatment decisions in breast and
colon cancers. The company is based in Redwood City, California with European
headquarters in Geneva, Switzerland. For more information, please visit,
www.GenomicHealth.com. To learn more about Oncotype DX tests, visit:
www.OncotypeDX.com and www.mybreastcancertreatment.org.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the ability of the company's Oncotype DX test to predict loco
regional recurrence in node positive breast cancer patients and the potential
ability of the test to be used in radiation treatment decisions; the
applicability of clinical study results to actual outcomes; the scope, success
or results of clinical trials and the timing of such activities; the ability
of the test to impact clinical practice; the expectations and timing for the
publication of the DCIS validation study; the ability of the company to
develop additional tests in the future; the attributes and focus of the
company's product pipeline; the potential economic benefits associated with
the company's tests; and the demand for the company's tests. 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 risks and potential delays
associated with such studies; the risks and uncertainties associated with
publication of the DCIS validation study; the risks and uncertainties
associated with possible additional regulation of the company's tests both in
the United States and abroad;; the risks associated with 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 quarter ended September 30, 2012. 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
SOURCE Genomic Health, Inc.
Contact: Investors, Dean Schorno, Genomic Health, +1-650-569-2281,
firstname.lastname@example.org, or Media, Victoria Steiner, Genomic Health,
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