ATLANTA, June 6 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced positive results from two studies that further demonstrate the value and clinical utility of quantifying gene expression to individualize treatment planning for early-stage breast cancer patients. These studies, along with findings from a gene identification study in colon cancer announced earlier this week, were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta.
“These consistent results across multiple studies are indicative of the steady progress we continue to make in our rigorous clinical efforts to provide quantitative information about cancer patients’ individual tumors that will help them make more informed treatment decisions with their physicians,” said Steven Shak, M.D., chief medical officer of Genomic Health. “With each study, we have learned more about how we can apply the RT-PCR technology used in the Oncotype DX test service for predicting response to different therapies as well as recurrence in various cancers.”
Predicting Response to Docetaxel in Breast Cancer
On Saturday, June 3, researchers from Genomic Health and Baylor-Methodist Breast Care Center presented findings from a study (Abstract #538) that evaluated tumor expression of 192 genes to predict response to docetaxel in patients with breast cancer. As a single agent chemotherapeutic, docetaxel is associated with one of the highest response rates; however, resistance is frequent.
This study evaluated small amounts of formalin-fixed, paraffin-embedded core biopsies from 72 patients with locally advanced breast cancer prior to treatment with neoadjuvant docetaxel for whom clinical response data was available. Complete responses were recorded in 17 percent of the patients, with another 57 percent demonstrating a partial response. A correlation between complete response and gene expression was seen in 14 genes, and patients with a high Recurrence Score were significantly more likely to be complete responders to docetaxel than those with a low Recurrence Score (p=0.008).
“These results establish a molecular blueprint for docetaxel-sensitive breast cancers and could lead to the development of a predictive test to reduce unnecessary treatment, toxicity and cost by ruling out patients who will not respond and only assigning it to those who will benefit,” said Jenny C. Chang, M.D., Associate Professor of Medicine at Baylor-Methodist Breast Care Center in Houston, TX.
Updated Economic Analysis Underscores Oncotype DX Value
Rochester, Albany, and Stanford investigators presented an updated Oncotype DX economic analysis on Tuesday, June 6 (Abstract #6024). Building on the original analysis published in the American Journal of Managed Care in May 2005, this update incorporated both prognostic and predictive information from more than 1,300 patients to evaluate the economic impact of the test service. Results showed that treatment guided by the use of the Oncotype DX Recurrence Score compared to tamoxifen alone were associated with greater efficacy with cost effectiveness ratios well within accepted ranges for new technologies. Furthermore the study revealed similar efficacy and substantially lower toxicity and cost associated with treatment guided by Oncotype DX compared to assigning tamoxifen plus adjuvant chemotherapy for all patients.
Colon Cancer Prognosis Genes Identified
Last week, the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health announced positive results of a new study (Abstract #3518) that identified genes associated with prognosis in patients with stage II and III colon cancer treated with surgery. Researchers analyzed RNA from 270 colon cancer patients enrolled in studies previously conducted by the NSABP between 1977 and 1984, including 128 patients with stage II disease and 142 patients with stage III disease. Of the 757 cancer-related and reference genes assessed, 142 genes exhibited an association with recurrence-free interval, or a period of time when the disease has not returned (nominal p-value <0.05). After controlling for routinely assessed clinical variables, 78 of these genes retained independent significance (p<0.05).
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test service 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. Oncotype DX 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 test service, Oncotype DX, 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the outcome or success of clinical trials or studies; the applicability of clinical study results to actual outcomes; the impact of clinical results on treatment decisions; the economic benefit and cost-effectiveness of our test service; the limitations of current treatment methods and their effect on patients; our clinical development strategy and progress; and our ability to develop and commercialize other test services and the specific attributes of any such test services. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including the risks set forth in Genomic Health’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. 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.
Genomic Health, Inc.
CONTACT: Emily Faucette of WeissComm Partners, +1-415-946-1066, forGenomic Health; or Brad Cole of Genomic Health, +1-650-569-2281