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Genomic Health, Inc. Announces Results From Six Studies Demonstrating Unique Value of the Oncotype DX Breast Cancer Test in Early Stage Breast Cancer  
12/10/2012 9:38:19 AM

REDWOOD CITY, Calif., Dec. 10, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the results from six studies of the Oncotype® DX breast cancer test presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) reinforcing the impact of the test on facilitating better informed treatment decisions in patients with node-negative and node-positive invasive early-stage breast cancer. Additionally, two studies demonstrated the test's cost effectiveness in invasive breast cancer and ductal carcinoma in situ (DCIS), adding to the large body of evidence of Oncotype DX's economic value across various healthcare systems.

"Our extensive body of clinical evidence showcases the ability of Oncotype DX to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide at this time when societies are seeking value from their healthcare spending," said Steven Shak, M.D., chief medical officer and executive vice president for research and development at Genomic Health. "With our knowledge of the human genome, the ability to sequence vast amounts of data using next generation technology and our proven ability to translate this into actionable information, we believe we are positioned to lead the delivery of new genomic tests that improve patient outcomes throughout their cancer journey."

Studies Continue to Reinforce Oncotype DX Provides Important Individualized Information That Can Not Be Revealed by Traditional Measures Alone

"Personalized medicine requires accurate, individualized assessment of the patient's tumor biology to enable better informed treatment decisions," said Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). "Oncotype DX is the only clinically validated multi-gene assay that gives a quantitative assessment of the risk of distant recurrence and has been proven to predict chemotherapy treatment benefit. The importance of understanding the continuous tumor biology is paramount to making the right treatment decisions for each individual patient."

The West German Study Group (WSG) presented data from the largest European study to date of more than 2,500 patients to include the Oncotype DX assay as a treatment decision tool. Results showed a wide range of Recurrence Score® results within the luminal A and B subtypes reinforcing that the individual Recurrence Score cannot be predicted by the luminal subtype, immunohistochemistry, or traditional clinical and pathologic measurements (Abstract: P2-10-08).




The WSG also presented an update from the Adjuvant Dynamic Marker-Adjusted Personalized Therapy (ADAPT) trial, which required the Oncotype DX Recurrence Score result for study entry in order to optimize risk assessment and therapy response prediction in early-stage breast cancer patients (Abstract: OT3-3-02).



An analysis of 67 patients comparing their Oncotype DX Recurrence Score result and MammaPrint classification demonstrated MammaPrint analysis did not deliver results in 15 percent of the samples, whereas Oncotype DX analysis successfully delivered Recurrence Score results for all the samples. The study also showed that the two tests classified patients differently in a large proportion of patients. Importantly, nearly half of the patients with high risk MammaPrint results had a low Recurrence Score, which indicates minimal, if any benefit from chemotherapy (Abstract: P6-07-03). The Oncotype DX test is the only genomic assay to predict chemotherapy benefit as consistently demonstrated in multiple randomized clinical trials with homogeneous and relevant patient population.



A large study of 1,065 early-stage, node-positive breast cancer patients treated with anthracycline (AC) containing chemotherapy as part of the NSABP B-28 trial supported that the Oncotype DX Recurrence Score is a robust predictor of distant recurrence, disease-free survival and overall survival in this patient population (Abstract: S1-10).




Additionally, in this study subset, the long term (median 11.2 years follow-up) benefit of adding paclitaxel to AC chemotherapy was not statistically significant. Given the overall benefit of adding paclitaxel to AC in the study cohort was small, and given that the Recurrence Score predicts the benefit of adding chemotherapy to hormonal therapy, it was not surprising that the Recurrence Score was not significantly associated with detecting the benefit of adding paclitaxel chemotherapy on top of AC chemotherapy. The primary objective of the B28 study was to examine the association between the Recurrence Score and local regional recurrence, which will be reported at the 2013 the Society of Surgical Oncology Cancer Symposium.

New Data Reinforced Cost-Effectiveness of Oncotype DX Use in Patients with Invasive Early Stage Breast Cancer and DCIS

  • Results from the third Oncotype DX health economics analysis of the Recurrence Score result in early-stage, estrogen receptor-positive, node-negative, patients in Japan demonstrated that chemotherapy use decreased by 19 percent with use of the test and was projected to be cost-effective in the region (Abstract: P5-15-06).
  • Additionally, a cost-effectiveness analysis of the Oncotype DX DCIS Score® compared to standard clinical assessment indicated that the use of the DCIS Score was more cost-effective than traditional clinical assessment (Abstract: P5-15-01).

About Genomic Health

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 September 30, 2012, more than 10,000 physicians in over 65 countries had ordered more than 320,000 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 company's belief that it is positioned to lead the delivery of new genomic tests that improve patient outcomes; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the potential economic benefits associated with the company's tests; the ability of the company to develop additional tests in the future; the demand for the company's tests; and the ability of any potential tests the company may develop to optimize cancer treatment. 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 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; our ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts; our ability to obtain capital when needed 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 owners.

SOURCE Genomic Health, Inc.


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