2014

Genomic Health Presents Ten New Studies in Breast, Colon and Prostate Cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting Data Reflect Company's Ongoing Commitment to Research, Development and Delivery of Innovative, Advanced Diagnostic Tests to Help Individualize Cancer Treatment Decisions

CHICAGO, June 4, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of ten studies being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, including a second large validation study confirming the performance of the Oncotype DX® colon cancer Recurrence Score® (RS) as an independent predictor of recurrence risk in stage II colon cancer.  The company also will present positive findings from a prostate gene identification study, as well as multiple studies in breast cancer including one suggesting that neoadjuvant treatment selection can also be guided by the underlying biology revealed by the Oncotype DX breast cancer test.

"Our continued research in breast, colon and prostate cancers add to the growing body of clinical evidence demonstrating the importance of understanding and treating a patient's underlying individual tumor biology," said Steven Shak, M.D., chief medical officer at Genomic Health,  "These ten studies presented at ASCO reflect our ability to continue adding value to the Oncotype DX breast and colon cancer tests that physicians use today, while accelerating our prostate cancer clinical development program, with the goal of making a test for biopsy specimens available to patients and physicians in 2013."

Research Highlights:

Colon Cancer:  

Second Successful Prospectively-Designed Study Confirms Oncotype DX Colon Cancer Test Provides Value Beyond Conventional Markers

Supporting the original QUASAR study presented at ASCO in 2009, new results from a separate large clinical validation study of stage II colon cancer patients enrolled in CALGB 9581 further confirms that the Oncotype DX Recurrence Score result improves the ability to differentiate higher from lower recurrence risk beyond conventional factors, such as tumor grade, number of nodes examined and lymphovascular invasion. Among patients with T3 stage II colon cancers with intact mismatch repair (MMR) protein function for whom conventional factors are uninformative, the Recurrence Score identified 22 percent of patients with an average risk of recurrence at 5 years above 20 percent providing an ability to accurately discriminate recurrence risk not available with conventional prognostic factors. A high colon cancer Recurrence Score reveals an underlying biology indicative of more aggressive disease for which adjuvant therapy may be more appropriately considered.

"These results, emphasizing Oncotype DX's precision, reproducibility and standardization, reinforce the potential value the test can provide for the large subset of stage II colon cancer patients who have T3 tumors which are MMR proficient," said Alan P. Venook, M.D., professor of clinical medicine, Gastrointestinal Oncology Research Program, University of California, San Francisco, and lead investigator of the study.  "Acquiring better understanding of the biology of an individual patient's disease enhances my ability to identify the most appropriate treatment plan for each patient, potentially sparing them from chemotherapy they do not need."

The study, "Validation of a 12-gene colon cancer recurrence score (RS) in patients (pts) with stage II colon cancer (CC) from CALGB 9581" (Abstract #3518) will be presented during a poster discussion on Monday, June 6.

Prostate Cancer:  

Gene Identification Results Support Development of a Prostate Cancer Test to Distinguish Indolent vs. Aggressive Disease

"This year, more than 200,000 men are expected to be diagnosed with prostate cancer, but few will benefit from aggressive treatments," said Eric Klein, M.D., chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic in Cleveland, Ohio. "If physicians had a better tool for more accurately determining whether or not a patient's disease is clinically significant, many men could avoid radiation therapy or surgery, as well as common treatment-related side effects such as loss of sexual function and incontinence."  

Results of a quantitative RT-PCR analysis of RNA specimens from 441 prostate cancer patients treated with radical prostatectomy (RP) at Cleveland Clinic between 1987 and 2004 identified 295 genes strongly associated with clinical cancer recurrence following radical prostatectomy.  The study, "Quantitative gene expression in primary and highest Gleason pattern cancer specimens identifies genes associated with clinical recurrence and prostate cancer -- specific survival after radical prostatectomy" (Abstract #4663) will be presented on Sunday, June 5.

A separate analysis of RNA from the same specimens indicated that there is no association of expression of TMPRSS2-ERG fusions or ERG expression with aggressiveness of prostate cancer after RP.  The study, "Use of TMPRSS2-ERG gene rearrangement and quantitative ERG expression to predict clinical recurrence after radical prostatectomy" (Abstract #4541) will be presented during a poster discussions session on Saturday, June 4.

Breast Cancer:

"This new analysis in the Canadian healthcare system reinforces evidence from multiple countries that use of the Oncotype DX assay to predict recurrence and response to adjuvant chemotherapy for women with early stage breast cancer provides good value for money," said John Hornberger, MD, MS, CEO, Cedar Associates and Adjunct Professor of Medicine, Stanford.  "Appropriate use of a clinically validated test that uncovers underlying biology that cannot be predicted by traditional clinical-pathologic measures, such as Oncotype DX, is clearly where clinical science needs to go. Economic policies should welcome and encourage these developments."

Oncotype DX Breast Cancer Saves Healthcare Costs in Canada

  • Results of an Ontario population-based group concluded that the use of Oncotype DX would result in more than $11 million per year savings to the health care system.  Researchers concluded the cost of the test would be offset by a reduction in costs associated with chemotherapy, with a potential to show even greater cost savings if adverse event costs were considered.  The study, "A cost benefit analysis of the 21-gene breast cancer assay within a Canadian health care system" (Abstract #6111) will be presented on Saturday, June 4.

Neoadjuvant Treatment Should be Guided by the Underlying Biology Revealed by the Oncotype DX Breast Cancer Test

  • An analysis of 64 postmenopausal patients in Japan with estrogen-receptor positive breast cancer who received exemestane, a steroidal aromatase inhibitor, concluded that the Oncotype DX breast cancer test has value in predicting a response to neoadjuvant endocrine treatment and provides evidence for the clinical usefulness of the Recurrence Score for neoadjuvant treatment selection.  Approximately 60 percent of the patients in the low and intermediate RS groups experienced a clinical response to exemestane as compared with 20 percent in the high RS group. The study, "A study of the recurrence score by the 21-gene signature assay as a predictor of clinical response to neoadjuvant exemestane for 24 weeks in estrogen-receptor positive breast cancer" (Abstract #558) will be presented on Monday, June 6.

  • In an interim assessment of 38 breast cancer patients who received ixabepilone in combination with cyclophosphamide as neoadjuvant chemotherapy treatment for HER2-negative breast cancer, tumors with higher Oncotype DX Recurrence Scores at baseline were more likely to achieve a pathologic complete response.  The study, "Ixabepilone and cyclophosphamide as neoadjuvant therapy in HER2-negative breast cancer with exploratory Oncotype DX assessments: A Sarah Cannon Research Institute phase II trial" (Abstract #1066) will be presented on Monday, June 6.

Breast Cancer Recurrence Score Cannot Be Predicted by Traditional Clinicopathologic Measures

  • An analysis of 2,097 patients from Clalit Health Services and 484 patients from Maccabi Health Services in Tel Aviv, Israel who received the Oncotype DX breast cancer tests between January 2008 and June 2010 concluded that the RS result cannot be predicted by traditional clinicopathologic measures, such as patient age, tumor grade, and tumor size.  The study, "Evaluation of recurrence score and traditional clinicopathologic assessments in a large ER-positive, lymph node-negative patient cohort" (Abstract #632) will be presented on Monday, June 6.

Additional Breast Cancer Studies Expand Understanding of Tumor Biology

  • Based on published data comparing the relative efficacy of aromatase inhibitors and tamoxifen in reducing the risk of distant recurrence, researchers concluded that an individual patient's Recurrence Score and Recurrence Score-Clinical-Pathologic (RSPC) distant recurrence risk assessment can be used to determine distant recurrence risk for early-stage breast cancer patients receiving treatment with an aromatase inhibitor.  The study, "Using the 21-gene Recurrence Score (RS) and the recently developed Recurrence Score-Pathology-Clinical (RSPC) to assess recurrence risk in patients with node-negative, ER-positive early-stage breast cancer receiving aromatase inhibitor treatment alone" (Abstract #592) will be presented on Monday, June 6.
  • Initial data from the prospective, multicenter West German Study Group (WSG) Plan B trial examined the relationship between tumor grade and the tumor immunohistochemistry biomarker, Ki-67, the invasion markers uPA (urokinase-type plasminogen activator) and its inhibitor PAI-1, and the Oncotype DX Recurrence Score. Results from a preliminary analysis of 1,795 patients showed that there were only weak correlations between all the markers and the Recurrence Score. These results reinforce the conclusion that the Recurrence Score result cannot be predicted by other clinicopathologic measures. The study, "Prospective comparison of recurrence score, uPA/PAI-1, central grade and molecular classification in early breast cancer: Interim results from the WSG-Plan B trial" (Abstract #10594) will be presented on Monday, June 6.
  • Results from an analysis of 5,644 early-stage breast cancer patients from a large US-based oncology group practice concluded that younger patients and patients who had better performance status and higher grade tumors were more likely to receive the Oncotype DX test.  The study, "Evaluating utilization characteristics for the Oncotype DX recurrence score in early-stage breast cancer" (Abstract #625) will be presented on Monday, June 6.
  • Finally, an analysis of 1,543 early-stage breast cancer patients from a large US-based oncology group practice demonstrated a strong association between RS values and adjuvant chemotherapy administration.  This study, "Evaluation of relation between Oncotype DX recurrence score and adjuvant chemotherapy administration" (Abstract #e11105) will be published online in conjunction with the 2011 Annual Meeting and citable to the Journal of Clinical Oncology as a supplement, but will not be presented at the meeting. 

About Genomic Health and the Oncotype DX® Tests

Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions.  

Its lead product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as risk for disease recurrence in early-stage breast cancer. The test is also validated for use in certain node-positive breast cancer patients.  Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology.  Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines* for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.

The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk for disease recurrence in patients with stage II colon cancer.   Five studies involving more than 3,200 patients have been conducted to validate the Oncotype DX colon cancer test.  

As of March 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 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 stages of 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.untileverywomanknows.com.

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 clinical utility of preliminary biomarkers for a prostate cancer test; our ability to develop and launch a test for prostate cancer in 2013;  the ability of the company to develop additional tests in the future; the ability of any tests the company may develop to optimize cancer treatment; the scope, success or results of clinical trials and the timing of such activities; the applicability of clinical study results to actual outcomes; and the ability of the company's tests to impact clinical practice. 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 possible additional  regulation of our tests both in the United States and abroad; 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 that our products may infringe the intellectual property of third parties;  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, 2011. 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 and Recurrence 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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