Two Large International Studies Provide Additional Prospective Data Reinforcing the Ability of Oncotype DX® to Accurately Predict Clinical Outcomes in Early-Stage Breast Cancer Patients

Presentations at 2015 European Cancer Congress Complement Watershed ECOG-ACRIN/NCI TAILORx Breast Cancer Study Results Published Today in The New England Journal of Medicine

Sep 28, 2015, 01:15 ET from Genomic Health, Inc.

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.



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