Genomic Health Reports Positive Results from Latest Clinical Validation Study of Oncotype DX

Genomic Health, Inc.

today announced strongly positive results from an additional independent clinical validation study of the Oncotype DX® prostate cancer test, conducted in collaboration with the Uniformed Services University of the Health Sciences' (USU) Center for Prostate Disease Research (CPDR) supported by a multi-disciplinary team of investigators under a cooperative research and development agreement with USU. This new large study reconfirmed the biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse pathology at surgery and, for the first time, validated GPS as a strong independent predictor of a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence). In meeting these two endpoints, the Oncotype DX prostate cancer test provides both clinically actionable and long-term outcomes information for men with newly diagnosed low- and intermediate-risk prostate cancer. Furthermore, the study demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men. The key results of this large prospectively-designed study in 402 patients are based on the CPDR multi-center national database, which has tracked men treated for prostate cancer within the Department of Defense healthcare system since 1990, and showed: o The biopsy-based Oncotype DX GPS was a robust and independent measure of multiple clinically relevant endpoints, including adverse surgical pathology (p<0.001) and long-term risk of biochemical recurrence after surgery (p<0.001); o The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian and African-American men regardless of their race. African-American men represented 20 percent of this study's patient population; o The established multiple prostate cancer-specific pathways contributed to the robust predictive value of the Oncotype DX GPS. The Oncotype DX GPS was also significantly predictive of metastatic prostate cancer recurrence (p = 0.032), a notable finding given the likelihood of metastases in patients with low- and intermediate-risk prostate cancer is so small. "There is a clear need for more accurate risk stratification and treatment optimization of men with newly diagnosed prostate cancer," said senior author David McLeod, M.D., director of CPDR and a professor of Surgery at USU. "Our rigorously conducted study provides further validation of the earlier studies at Cleveland Clinic and University of California, San Francisco, which showed the Oncotype DX prostate cancer test is an independent predictor of clinical outcomes to inform decisions regarding active surveillance versus immediate treatment in patients with low- and intermediate-risk disease." In this study, GPS results were obtained using archival biopsy tumor tissue from 402 men, including 82 African-American patients, treated with radical prostatectomy for NCCN very low-, low- or intermediate-risk prostate cancer at two U.S. military medical centers between 1990 and 2012. The analysis showed that GPS distribution was very similar between African-American and Caucasian patients. Additionally, specific gene groups incorporated in GPS – androgen signaling and stromal response – were more strongly associated with biochemical recurrence, while all four biologic pathways measured by GPS were significant predictors of adverse pathology. The CPDR is a multi-disciplinary prostate cancer research program of the Department of Surgery at USU, the U.S. Department of Defense's federal health sciences university. The center is a collaboration with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a private,    not-for-profit organization authorized by Congress to support medical research and education at USU. Developed and validated in collaboration with the University of California, San Francisco and Cleveland Clinic, the Oncotype DX prostate cancer test addresses the unique challenges in making treatment decisions for men with low-risk, clinically localized prostate cancer by identifying patients who can consider active surveillance with greater confidence and thus avoid unnecessary treatment, as well as those men who have more aggressive disease and should consider immediate treatment. This genomic test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. It provides a GPS result on a scale that ranges from 0 to 100, and is combined with other clinical factors to further clarify a man's risk prior to treatment intervention.   "This new landmark study reconfirms the clinical validity of the Oncotype DX prostate cancer test and adds to the recently published UCSF and Cleveland Clinic studies," said Phil Febbo, M.D., chief medical officer, Genomic Health. "These new results provide the first validation of our test's ability to predict biochemical recurrence and a second, independent validation of its ability to predict adverse pathology. By measuring biology associated with both near- and long-term outcomes, the test provides important and practice-changing information to patients and physicians." Additional Oncotype DX data presented at the ESMO 2014 Congress included previously presented studies in breast and renal cancers, highlighting further evidence of the impact of the Oncotype DX test in breast cancer treatment across multiple health care systems and the importance of assessing multiple, disease relevant, biological pathways to predict tumor behavior and the best course of treatment.