REDWOOD CITY, Calif., May 23 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced that the Journal of Clinical Oncology (JCO) published results of a large-scale trial conducted with the National Surgical Adjuvant Breast and Bowel Project (NSABP) confirming the Oncotype DX 21-gene panel, which quantifies the risk of breast cancer recurrence, also predicts the likelihood of response to chemotherapy in a large portion of women with early-stage breast cancer. This study successfully challenges the common assumption that all women benefit similarly from chemotherapy and follows the publication of an earlier large Oncotype DX study published in The New England Journal of Medicine in 2004.
JCO is publishing the study today online as an “early release” to coincide with the launch of TAILORx (Trial Assigning IndividuaLized Options for Treatment [Rx]), a first-of-its-kind individualized treatment trial that will utilize Oncotype DX to identify and assign treatment to more than 10,000 women from 900 sites in the United States and Canada. Findings from the NSABP study helped guide the development of the TAILORx trial, which the National Cancer Institute (NCI), part of the National Institutes of Health, announced today at the NCI Science Writers’ Seminar. The NSABP study also will appear in JCO’s August print edition.
Oncotype DX uses RNA analysis of tumor tissues to measure the expression profile of a panel of 21 genes demonstrated to be involved in breast cancer, including those related to the estrogen receptor, the HER2 gene and proliferation, as well as several other pathways. Based on results of the test, a Recurrence Score from 0-100 is determined.
“The clinical implications of these results for patients with low or high Recurrence Scores are clear, and have helped guide subsequent treatment decisions for many women following their original presentation at the 2004 San Antonio Breast Cancer Symposium,” said Soonmyung Paik, M.D., director of the NSABP Division of Pathology. “With TAILORx, we hope to gain a better understanding of the effects of chemotherapy for those patients with midrange scores, building upon what we’ve already learned in an effort to individualize treatment for all women with early-stage breast cancer.”
The NSABP B-20 chemotherapy benefit study evaluated 651 patients (227 randomized to tamoxifen and 434 randomized to tamoxifen plus chemotherapy). Results demonstrated that breast cancer patients with high Recurrence Scores and high risk of recurrence, as identified by the Oncotype DX assay, had large benefits from chemotherapy. Patients with low Recurrence Scores and low risk of recurrence had only minimal, if any, benefit from chemotherapy. The magnitude of chemotherapy benefit could be predicted from the Recurrence Score. These results, published today in the Journal of Clinical Oncology, led to the TAILORx trial, which aims to assess the effects of chemotherapy in a group of women with midrange Recurrence Scores and risk of recurrence.
NCI Announces TAILORx Clinical Trial for Individualized Treatment
Coordinated by the Eastern Cooperative Oncology Group (ECOG), TAILORx is designed to evaluate the effect of chemotherapy in women with a midrange risk of their cancer returning, as determined by Oncotype DX, Genomic Health’s breast cancer test service that quantifies the likelihood of breast cancer recurrence and predicts the likelihood of response to chemotherapy for many early-stage breast cancer patients. TAILORx will be one of the largest adjuvant treatment trials in breast cancer ever conducted, and recently opened to begin enrolling newly diagnosed women throughout the country.
“TAILORx represents the culmination of a major initiative to integrate molecular diagnostic testing into clinical decision making,” said Joseph Sparano, M.D., principal investigator for the Eastern Cooperative Oncology Group (ECOG) and director of the Breast Evaluation Center at the Montefiore- Einstein Cancer Center in New York. “This is the first trial from the NCI’s Program for the Assessment of Clinical Cancer Tests (PACCT), which seeks to individualize cancer treatment by using, evaluating and improving the latest diagnostic tests. Oncotype DX makes this trial possible by enabling us to separate women with high and low scores, whose treatment paths are clear, from those who fall in the midrange.”
Researchers will utilize the Oncotype DX test to quantify each patient’s individual risk of recurrence in order to assign them to the appropriate treatment. Women with a Recurrence Score greater than 25 will receive chemotherapy plus hormonal therapy; women with a Recurrence Score less than 11 will receive hormonal therapy alone; and those with a midrange Recurrence Score from 11-15, the primary study group, will be randomized to receive hormonal therapy with or without chemotherapy. This trial will evaluate the effect of chemotherapy only for those with a midrange Recurrence Score, as previous Oncotype DX studies have already confirmed the benefit of adjuvant chemotherapy for those in the high Recurrence Score range and minimal, if any, benefit for those in the low Recurrence Score range.
“The use of Oncotype DX in this trial further demonstrates how our test can be used as a critical tool to help physicians tailor breast cancer treatment regimens based on individual patient characteristics,” said Steve Shak, M.D., chief medical officer at Genomic Health. “TAILORx will make it possible for the medical community to take its knowledge of the Recurrence Score one step further by gaining an understanding of which patients at ‘midrange risk’ might benefit most from chemotherapy in addition to hormonal therapy.”
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. The test has been extensively evaluated in multiple independent studies involving more than 2,600 breast cancer patients, 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. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first service, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and chemotherapy benefit in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
About the Eastern Cooperative Oncology Group
The Eastern Cooperative Oncology Group (ECOG) is one of the largest cancer research organizations in the United States. It has a network of researchers, physicians, and healthcare professionals at public and private institutions across the country. ECOG conducts clinical trials in all types of adult cancers and receives funding from the National Cancer Institute (NCI) and other sources. ECOG’s goal is to control, effectively treat, and ultimately cure cancer. ECOG provides research results to individuals and the medical community through scientific publications and professional meetings.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expansion of the predictive value of our test, particularly to patients with midrange Recurrence Scores and risks of recurrence, the potential clinical implications regarding therapy decisions, the extent to which the use of Oncotype DX in the TAILORx trial results in increased physician use or acceptance of our test service, the parameters and outcome of the TAILORx trial and the applicability of clinical study results to actual outcomes. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, which is on file with the Securities and Exchange Commission and is available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. We disclaim 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.
Genomic Health, Inc.
CONTACT: Emily Faucette of WeissComm Partners, +1-415-595-9407, or BradCole of Genomic Health, +1-650-569-2281
Web site: http://www.genomichealth.com/
