Genomic Health Announces Publication of QUASAR Study Confirming Oncotype DX® Predicts Individualized Recurrence Risk for Stage II Colon Cancer Patients
REDWOOD CITY, Calif., Nov. 8, 2011 /PRNewswire/ -- Genomic Health, Inc. today announced that the Journal of Clinical Oncology (JCO) published positive results from the landmark QUASAR clinical validation study, which demonstrated that the Oncotype DX® colon cancer test predicts recurrence risk in stage II colon cancer patients following surgery. The findings, published today online as an "early release," also establishes that the Oncotype DX colon cancer Recurrence Score® (RS) provides additional clinical value beyond conventional markers such as T-stage, mismatch repair (MMR) status, nodes examined, grade and lymphovascular invasion. In September, Medicare established a formal coverage policy for the Oncotype DX colon cancer test.
"The Oncotype DX colon cancer test was made available in 2010 based on results from the QUASAR study, allowing physicians to go beyond the limited set of clinical and pathologic markers to make more informed decisions about the adjuvant use of chemotherapy for stage II colon cancer based on the quantitative individualized assessment of recurrence risk," said Steven Shak, M.D., chief medical officer at Genomic Health. "These results, together with the positive confirmatory clinical study presented by the CALGB at ASCO in June and Medicare's recent coverage announcement, pave the way for expanded reimbursement and increased patient access to the Oncotype DX colon cancer test."
The QUASAR clinical validation study analyzed 1,436 patients with stage II colon cancer.
The researchers found that recurrence risk increased with increasing Recurrence Scores, with an average recurrence risk at three years of 12 percent, 18 percent and 22 percent in the pre-defined low, intermediate and high recurrence risk groups, respectively. The study further demonstrated that the Recurrence Score provides a continuous measure of recurrence risk at three years, ranging from a lowest risk of 9-11 percent to a highest risk of 25-27 percent.
"A strength of this study is the rigorous statistical analysis, and the use of an independent study, our landmark QUASAR trial, to test the validity of the Recurrence Score," said Richard Gray, professor of medical statistics at the Universities of Oxford and Birmingham. Richard Gray, David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford, and Philip Quirke, B.M., M.D. FRCPath, professor of pathology and tumor biology at the University of Leeds, are the principal investigators of the QUASAR validation study.
Reconfirming the importance of tumor biology guiding colon cancer treatment decisions, the Oncotype DX Recurrence Score was found to predict recurrence risk (p=0.006), when analyzed in the presence of the clinical and pathological factors traditionally used by physicians to assess stage II colon cancer patients. T4 stage (p=0.004) and MMR deficiency (p=0.004) were also independently beneficial in predicting recurrence, and together comprise approximately 25 percent of patients. T4 stage indicates growth of the tumor through the wall of the bowel and is associated with higher risk of recurrence. MMR deficiency is closely related to a high degree of MSI (microsatellite instability), and is an alteration observed in approximately 15 percent of stage II colon cancers. For patients with T3, MMR proficient 'standard risk' tumors, who constitute the majority of stage II colon cancer (more than 70 percent), the Oncotype DX Recurrence Score provides important recurrence risk information for the individual patient not previously available with conventional clinical and pathologic markers.
Patients with stage II colon cancer whose tumors are determined to be MMR deficient have a low risk of recurrence. With this result, QUASAR represents the largest study to confirm the importance of MMR in stage II colon cancer. Based on the significance of this finding, Genomic Health plans to start providing MMR IHC testing services to help physicians assess mismatch repair status for stage II colon cancer recurrence risk later this year. Additionally, the company has completed laboratory analysis of the gene identification study to predict the benefit of oxaliplatin chemotherapy in stage II and III colon cancer patients, using samples from the landmark NSABP C-07 study. The results are expected to be reported in 2012 following the completion of data analysis.
More than 150,000 people worldwide are diagnosed with stage II colon cancer each year. The decision to treat patients with chemotherapy following surgery is based on an assessment of how likely their disease is to recur. More accurately identifying those patients with high recurrence risk based on the underlying tumor biology allows patients to make more informed decisions regarding whether to use chemotherapy or not.
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 recurrence in early-stage breast cancer to help optimize treatment options. 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.[1] The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO).
Physicians also use the Oncotype DX Breast Cancer test to make treatment recommendations for 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.
The Oncotype DX Colon Cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer. The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.
As of September 30, 2011, more than 10,000 physicians in over 60 countries had ordered more than 230,000 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 the Company's belief that the publication of the Quasar clinical validation study will enable broader access to its colon cancer test and result in sales and reimbursement progress for its colon cancer test; that the company's tests impact clinical decision making; the value the company's tests are delivering to physicians, payers and patients; the company's plans to expand its colon cancer offering to include IHC testing for MMR status to assess mismatch repair for stage II colon cancer risk; the results of studies to predict the benefit of oxaliplatin in stage II and II colon cancer patients; the applicability of study results to clinical practice and the ability of the test to optimize cancer treatment. 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 competition and commercialization of the test; the risk that the company will not be able to establish further insurance coverage or maintain reimbursement for the test; regulation of the company's tests; 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 Quarterly Report on Form 10-Q for the period ended June 30, 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.
[1] ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively. ASCO and NCCN do not endorse any product or therapy.
SOURCE Genomic Health, Inc.
