Genomic Health Announces Results of Ten Studies in Breast, Prostate and Colon Cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting

REDWOOD CITY, Calif., May 31, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of 10 studies being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, underscoring the company's commitment to optimizing cancer treatment.  New data include studies of the Oncotype DX® RT-PCR-based breast, colon and prostate cancer tests and a large next generation sequencing (NGS) study that reports novel methods for detection of gene fusions to enhance the understanding of breast cancer tumor biology for future clinical developments.

"Through continued research in breast, colon and prostate cancers, and our next generation sequencing program, we continue to lead the way in how to translate vast amounts of genomic data into actionable information to improve health outcomes by eliminating 'one-size-fits-all' treatment in cancer," said Steven Shak, M.D., chief medical officer at Genomic Health.  "The new Oncotype DX research reflects our commitment to expanding our understanding of the biology of cancer and clinical utility of our tests for cancer patients throughout the course of their disease."

Breast Cancer

"As physicians continue to strive to deliver on the promise of precision medicine, Oncotype DX represents a critical tool to enhance our ability to treat every breast cancer patient based on her individual biology," said Lee Schwartzberg, M.D., medical director of the West Clinic Memphis, Tenn. "The new data on this test adds to the large body of evidence illustrating the clinical value of Oncotype DX for patients and physicians, highlighting the test's ability to change treatment decisions in the real-world clinical setting."

Oncotype DX Provides Prognostic Information in Metastatic Breast Cancer

• The study evaluated the association between the Recurrence Score and time to progression and overall survival in patients with advanced breast cancer enrolled in TBCRC 013, a registry evaluating the primary tumor in patients presenting with stage IV disease.  Researchers concluded that Oncotype DX is prognostic for time to progression and for overall survival in ER positive, HER2 negative stage IV breast cancer, and provides information beyond that provided by patient age, tumor size, and the site of the metastasis. 
  The new findings, discussed in an oral presentation, suggest that a high Recurrence Score may influence treatment decisions for patients with metastatic disease and add to the body of evidence supporting the value of the Oncotype DX test across the continuum of breast cancer, including pre-invasive (DCIS), early-stage invasive node negative and node positive disease, and now in advanced breast cancer. (Abstract #507)

Results Reconfirm High Concordance of HER2 Assessment by Oncotype DX, Central IHC and FISH

• Results of this NCCTG cooperative group study in 901 patients treated with adjuvant trastuzumab (Herceptin) demonstrated that quantitative reporting for HER2 gene expression, as measured by the Oncotype DX breast cancer test using the RT-PCR platform, had a greater than 90 percent concordance with both fluorescence in situ (FISH) and immunohistochemistry (IHC) testing. Genomic Health began including HER2 single gene expression in 2008 as part of the Oncotype DX Recurrence Score results, with the goal of providing added biological insight into a patient's tumor in cases where HER2 results by IHC and FISH are uncertain or conflicting.  These new results are consistent with two previously published positive concordance studies comparing RT-PCR, IHC and FISH performed in collaboration with Kaiser Permanente and the Eastern Cooperative Oncology Group.
  The study also explored the association between the Recurrence Score and adjuvant trastuzumab (Herceptin) benefit, and suggests as has been reported previously, that there may be some benefit of trastuzumab in the adjuvant breast cancer setting for patients with low levels of HER2 expression.  The findings support further research including investigation of gene expression and mutations using next generation sequencing (NGS) that might identify more patients who can benefit from Herceptin.  (Abstract #520)

Initial Results from the Oncotype DX Breast Cancer Test Registry Further Expand Information about Test's Real-World Impact on Treatment Decisions

• A large prospective observational study involving 890 patients enrolled at 16 U.S. sites between November 2009 and March 2012 analyzed the real-world use of the Oncotype DX test in clinical practice to evaluate the association between Recurrence Score results and treatment decisions. The findings demonstrated a wide range of Recurrence Score results within the different clinical and pathologic categories: patients with low Recurrence Score results were more likely to receive hormonal therapy alone, whereas patients with a high score were more likely to also receive chemotherapy. This trend was observed across categories of patient age, tumor grade and size, and nodal status, demonstrating the impact of the Recurrence Score on chemotherapy treatment decisions.
  The results of this first analysis of the registry are consistent with previously-described distribution of Recurrence Score values and clinical experience, emphasizing the importance of understanding a patient's breast cancer biology in order to make more informed and individualized treatment decisions.  (Abstract #565)

Continued Research in Next Generation Sequencing (NGS) Suggests that Gene Fusions May Contribute To Breast Cancer Progression

• Building on previously published research demonstrating the ability to conduct whole transcriptome RNA-Seq on fixed paraffin-embedded breast cancer tissue samples, this exploratory NGS study in a total of 212 patients used new analytical and bioinformatic methods to identify 100 novel breast cancer gene fusions. A number of these gene fusions were observed to associate with a worse clinical outcome. Importantly, while the vast majority of these gene fusions were unique to individual patients, some were shared among several patients, including a novel fusion involving the estrogen receptor gene. (Abstract: 11018)

Prostate Cancer

Broader Understanding of Information Provided by Recently Launched Oncotype DX Prostate Cancer Test Supports Its Ability to Reveal Underlying Biology

• The recently launched Oncotype DX prostate cancer test assesses tumor tissue from diagnostic needle biopsies and provides information beyond standard clinical factors, such as PSA and biopsy Gleason Score, to help physicians and their prostate cancer patients confidently choose the most appropriate treatment based on  risk assessment.  Based on the initial development study conducted in collaboration with Cleveland Clinic, this investigation evaluated whether gene expression patterns in normal-appearing tissue adjacent to areas of tumor involvement, including the Oncotype DX Genomic Prostate Score (GPS), are predictive of clinical outcomes.  The results show that the GPS and other genes, assessed in normal-appearing tissue adjacent to the tumor, were predictive for clinical recurrence and prostate cancer-specific mortality, suggesting that there is an underlying field effect associated with the development of aggressive prostate cancer.  (Abstract #5029)

Colon Cancer

Use of Oncotype DX Colon Cancer Test Significantly Changes Treatment Decisions and Reduces Medical Costs

• An analysis of 141 patients from 17 sites in the Mayo Clinic Cancer Research Consortium provided real-world confirmation that in patients with stage II colon cancer, the Oncotype DX colon cancer test can impact treatment decisions and leads to reduction in direct medical costs while preserving quality-adjusted life years. In addition to showing the decision impact where physician recommendations for adjuvant chemotherapy decreased by 22 percent after receiving the Recurrence Score results, an economic impact analysis model projected cost savings of $1,683 per patient.  (Abstract #3640)

Additional Oncotype DX Studies Presented at ASCO Include:

• An analysis evaluating the differences in Oncotype DX score among Hispanic and Caucasian women concluded that Hispanic women with estrogen receptor-positive, HER2 negative, early-stage breast cancer have higher tumor proliferation markers than Caucasian women. (Abstract #560)
• A comparative analysis of distant recurrence risk assessment by Oncotype DX alone, and integrated with pathology and clinical measures. (Abstract #598)
• An overview of the Adjuvant Dynamic marker-Adjusted Personalized Therapy (ADAPT) trial, which is designed to optimize risk assessment and therapy response prediction in early-stage breast cancer.  (Abstract #TPS655)
• A prospective analysis of the use of the Recurrence Scores to select pre-operative chemotherapy for patients with hormone receptor-positive breast cancer.  (Abstract #562)

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 and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of March 31, 2013, more than 19,000 physicians in over 70 countries had ordered more than 350,000 Oncotype DX tests.  Genomic Health has a robust pipeline focused on developing tests to further optimize the treatment of breast, colon and prostate cancers, as well as the treatment of renal cancer.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland.  For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.  

Forward Looking Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our ability to generate similar results in further studies; the applicability of the Oncotype DX Breast Cancer test to metastatic patients; the ability of the Oncotype DX Prostate Cancer test to identify aggressive disease;  the applicability of clinical study results to actual outcomes; the ability of the company's tests to impact clinical practice ; the ability of  the company tests, including its colon cancer test,  to optimize cancer treatment or to reduce direct medical  costs ; the ability of the company to develop and commercialize additional tests in the future; and  the scope, success or results of clinical trials and the timing of such activities. 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 our tests; the risks associated with competition; the applicability of clinical study results to actual outcomes; the risks associated with the commercialization of current and future products; the risks and potential delays associated with such studies; 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 March 31, 2013. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

SOURCE Genomic Health, Inc.