Genomic Health Announces Launch of NCI RxPONDER Trial Utilizing Oncotype DX® in Women with Node-Positive Breast Cancer Trial Represents Second Large NCI Study Using Oncotype DX to Select Patients For Treatment Based on the Underlying Biology
REDWOOD CITY, Calif., April 26, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the launch of RxPONDER S1007 (Rx for Positive Node, Endocrine Responsive Breast Cancer), a clinical trial being led by SWOG, one of the largest National Cancer Institute (NCI) supported cancer cooperative groups. The trial is designed to determine the effect of chemotherapy in breast cancer patients with one to three positive nodes who have a Recurrence Score® (RS) result equal to, or less than, 25 as determined by the Oncotype DX® breast cancer test.
"Based on results from the previous SWOG 8814, E2197 and transATAC studies, which support the use of Oncotype DX in patients with node-positive breast cancer, as well as positive results from a decision impact study recently published in the Journal of Oncology Practice, many physicians have used the Oncotype DX test in their patients with node-positive breast cancer and certain payors have started covering the test's use in these patients," said Steven Shak, chief medical officer at Genomic Health. "We are excited to partner again with the NCI and national cancer cooperative groups on the RxPONDER trial as it will allow us to gain additional insights beyond the earlier studies by identifying a more precise Recurrence Score cut-off that can be used to determine when chemotherapy is not beneficial for patients in this population."
Researchers will utilize the Oncotype DX breast cancer test to quantify each patient's individual risk of recurrence in order to assign them to the appropriate treatment. Women who have tumors with a RS result equal to, or less than, 25, the primary study group, will be randomized to receive hormonal therapy with or without chemotherapy. Women who have tumors with a high RS, greater than 25, will be offered chemotherapy plus hormonal therapy as standard of care, or in the context of other clinical studies. Since about 20-40% of patients will have tumors with RS greater than 25 and some women may not choose to be randomized, researchers expect to screen more than 9,000 breast cancer patients using the Oncotype DX test to identify the 4,000 patients with a RS result equal to, or less than, 25. While the trial is being led by SWOG, it is expected to be opened by the other major cooperative groups as well, giving patients wide access to the trial throughout the world.
"In the U.S., each year, more than 60,000 women are diagnosed with hormone receptor-positive breast cancer that has spread to their lymph nodes and almost all of them receive chemotherapy in addition to hormone therapy," said study coordinator Ana M. Gonzalez-Angulo, M.D., of the MD Anderson Cancer Center. "The RxPONDER trial will give us important information about more precise use of a genomic-based test that could spare some of these women the grueling side effects of chemotherapy they don't need while saving the healthcare system money."
About the Oncotype DX® Breast Cancer Test*
The Oncotype DX breast cancer test is a multigene expression test that examines a breast cancer patient's tumor tissue at a molecular level, and gives information about their individual disease to help optimize treatment options. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines to predict the likelihood of chemotherapy benefit as well as recurrence for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.
Additionally, physicians use Oncotype DX to make treatment recommendations for certain node-positive breast cancer patients, and the test report also provides quantitative scores for select individual genes. 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. Both Medicare and private health plans covering over 95 percent of U.S. insured lives provide reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. For more information about Oncotype DX for breast cancer, please visit www.oncotypedx.com or www.untileverywomanknows.com.
*ASCO® is a registered trademark of the American Society of Clinical Oncology. NCCN® is a registered trademark of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any product or therapy.
About Genomic Health
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 recurrence in early-stage breast cancer. In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of December 31, 2010, more than 10,000 physicians in over 60 countries had ordered more than 190,000 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.
SWOG (formerly the Southwest Oncology Group) is one of the largest cancer clinical trial cooperative groups in the United States. Funded primarily by the National Cancer Institute (NCI), the group designs and conducts clinical research trials to improve the practice of medicine in preventing, detecting, and treating cancer and to enhance the quality of life for cancer survivors. The more than 4,000 physician-researchers in the group's network practice at more than 500 institutions, including 19 of the NCI-designated cancer centers. The Group is headquartered at the University of Michigan in Ann Arbor, Mich. (734-998-7140). The Group has an operations office in San Antonio, Texas and a statistical center in Seattle, Wash. Learn more at swog.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 belief that the Oncotype DX can predict chemotherapy benefit in node positive breast cancer patients; the anticipated size of the study and the company's belief that the study may be expanded to include other cooperative groups throughout the world; the company's belief that the Oncotype DX is cost effective to the healthcare system; the company's belief that it has the opportunity to advance the quality of cancer treatment decisions; the belief that study data may warrant or result in additional clinical studies or impact treatment decisions; 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, 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; risks related to the timing and level of participation in the study; the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 Annual Report on Form 10-K for the year ended December 31, 2010 . 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.