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Genomic Health Announces Results Of Eighteen Studies Covering Colon, Prostate And Breast Cancers At The American Society For Clinical Oncology (ASCO) 2012 Annual Meeting

REDWOOD CITY, Calif., June 1, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of 18 studies being presented at the American Society for Clinical Oncology ® (ASCO ®) Annual Meeting taking place June 1-5 in Chicago, Illinois.  New data includes validation of the Onco type DX ® colon cancer test in both stage II and stage III disease, the company's first prostate needle biopsy development study, and further evidence of the clinical value of the Onco type DX DCIS Score result.  The company also will present multiple studies in breast cancer reconfirming the clinical utility and cost effectiveness of the Onco type DX Recurrence Score® for invasive breast cancer.

"Our continued research in breast, colon and prostate cancers support our belief that molecular diagnostics are essential for optimizing patient treatment across tumor types, at multiple stages of disease," said Steven Shak, M.D., chief medical officer at Genomic Health.  "The results of these eighteen studies add to the growing body of clinical evidence demonstrating the worldwide value Onco type DX tests bring to physicians, patients and payors, while accelerating our research and clinical development efforts in other cancers, like prostate."

Colon Cancer: Third Successful Prospectively Designed Study of Oncotype DX Colon Cancer Test In Patients with Stage II Disease, First Validation Study in Patients with Stage III Disease (Abstract #3512); Separate Study Demonstrates 29 percent Change in Treatment Recommendations in Stage II Colon Cancer Patients (Abstract #3626)
  • A large, prospectively-designed, independent validation study involving 892 patients demonstrates that the Onco type DX Colon Cancer Recurrence Score predicts risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy in the landmark randomized NSABP C-07 clinical trial (p<0.001 for all endpoints).  These new data reconfirm the value of the colon cancer Recurrence Score result in revealing underlying biology that provides quantitative information regarding recurrence risk not available with conventional factors, such as T-stage, N-stage, mismatch repair (MMR) status, tumor grade, and nodes examined.  The study also indicates that risk assessment with Recurrence Score result enables better discrimination of the expected absolute benefit of adding oxaliplatin to adjuvant 5FU chemotherapy (Abstract #3512). Based on these findings, as of June 11, Genomic Health will extend its offering of the Onco type DX colon cancer test as the first standardized, clinically validated, commercially available multi-gene test to differentiate risk of recurrence for patients with stage III disease and in the context of oxaliplatin-containing adjuvant therapy.  Separately, the company is also evaluating additional genes in these patients to identify new genes which would be specifically predictive of oxaliplatin benefit, and plans to report results later this year.

"This study reinforces how the Onco type DX colon cancer test can help physicians use a patient's tumor biology to more accurately assess their recurrence risk, in a manner not previously possible with clinical and pathologic factors. Importantly, by improving recurrence risk assessment, Onco type DX also provides stage II and stage III colon cancer patients with a better understanding of the expected absolute benefit with the addition of oxaliplatin to adjuvant 5FU therapy, a conclusion which is only possible through studies in randomized clinical trials like NSABP C-07, " said principal investigator Michael O'Connell, M.D., associate chairman of The National Surgical Adjuvant Breast and Bowel Project (NSABP).  "The Recurrence Score has shown us that there is a continuous biology in colon cancer versus a high or low ranking, and understanding where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients make more informed decisions regarding adjuvant therapy."
  • A separate study in 92 evaluable stage II colon cancer patients demonstrates that knowledge of a patient's Recurrence Score result changes medical oncologists' treatment recommendations in 29 percent of cases.  Among the physician recommendations that changed, two-thirds (67 percent) reflected a decrease in treatment intensity and one-third (33 percent) reflected an increase in treatment intensity (Abstract #3626).

Prostate Cancer: Company's First Clinical Study in Prostate Needle Biopsies Demonstrates Biology Observed in Prostatectomy Tissue can be Measured in Limited Tissue Sampled with Needle Biopsy (Abstract #4560)
  • An analysis of 167 biopsy samples from men with conventionally defined low/intermediate risk prostate cancer shows that the genes and biological pathways associated with clinically-aggressive prostate cancer in radical prostatectomy specimens can be reliably measured by quantitative RT-PCR from fixed prostate needle biopsies.  The study results show that this biology, measured in the small amounts of tumor tissue obtained through needle biopsies, was associated with the occurrence of adverse pathology or favorable pathology in the prostatectomy specimens. Based on this and multiple prior studies, Genomic Health also has initiated a clinical validation study for its prostate cancer test, performed in collaboration with the University of California, San Francisco. The study is designed to determine if a multi-gene test can help patients with early stage prostate cancer by distinguishing aggressive disease requiring immediate treatment, such as surgery, from indolent disease which may be appropriately managed with active surveillance. The company plans to announce topline results later this year. 

DCIS Breast Cancer: New Data Reinforce Oncotype DX DCIS Score Provides Independent Recurrence Risk Information for Patients with Pre-Invasive Disease (Abstract #1005)
  • Previously, ECOG investigators presented positive validation study results in 327 women with DCIS (ductal carcinoma in situ of the breast) at the San Antonio Breast Cancer Symposium in December 2011 demonstrating that the Onco type DX DCIS Score result can help identify patients who are at high or low risk for a local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. Additional results from the E5194 DCIS clinical validation study presented at ASCO provide further evidence that the DCIS Score result provides clinical value beyond traditional factors, such as tumor grade. Moreover, the results indicate that the DCIS Score result cannot be predicted using the available clinical or pathology factors. The Onco type DX test for DCIS, which was launched at the end of last year, can identify both lower risk DCIS, which may be treated with surgery alone, and higher risk DCIS, for which radiation should be considered in addition to surgery. 

"Although previous studies such as NSABP B-17 showed that patients with DCIS breast cancer benefitted from radiation, the issue in DCIS has been the absence of a reliable way to specifically identify those patients that are at such low risk of recurrence that they can forego radiation," said Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP).  "The Oncotype DX DCIS Score is a critical first step towards quantifying the risk of recurrence for patients with DCIS who have been surgically excised and identifying patients with a low enough risk of recurrence that radiation can be omitted from their treatment."

Highlights of Select Studies in Invasive Early-Stage Breast Cancer: Multiple Studies Reconfirm Oncotype DX Breast Cancer Test's Clinical Utility, Impact on Treatment Decisions, and Cost Effectiveness
  • Results of the first Onco type DX breast cancer test treatment decision impact study from Canada shows that in 150 patients who used the test, the knowledge of the Recurrence Score result changed physicians' treatment recommendation for 30 percent of invasive early-stage breast cancer patients.  The study conducted by the British Columbia Cancer Agency demonstrated that, based on the Recurrence Score result, 20 percent of patients were advised to omit chemotherapy and use hormonal therapy alone, and 10 percent of patients were advised to add chemotherapy to hormonal therapy. Within the context of a publicly funded health care system, use of the Recurrence Score also significantly reduced patient decisional conflict (Abstract #549)  A separate study from France shows similar treatment decision impact of using the Onco type DX test, with overall reduction in chemotherapy recommendations from 49 percent to 26 percent of patients. (Abstract #568).  These new results are consistent with 15 previous Onco type DX breast cancer decision impact studies conducted across multiple countries.
  • An updated analysis of the Recurrence Score results in 465 patients from a phase III intergroup trial was reported by ECOG investigators. Now, with 11.5 years of median follow-up, the Recurrence Score result continues to be a significant predictor of recurrence, and provides information that is complimentary to traditional clinical and pathology factors in women with early stage node positive and high risk node negative breast cancer. (Abstract #1021)
  • Three studies evaluating Onco type DX testing in clinical practice indicate that treatment recommendations, while appropriately correlated with Recurrence Score results, are also related to physician prescribing preferences.  Results also showed that physicians' individual choices may lead to underuse of Onco type DX testing in eligible patients, and when testing is performed, underutilization of chemotherapy in the high-risk patients.  Further studies are needed to better understand the variation in physician practice. (Abstracts #6098, 569, 571)
  • Updated cost-effectiveness estimates based on two recently-published studies reconfirm the economic value of the Onco type DX test in the setting of node-negative, ER positive invasive breast cancer. (Abstract #1525)


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