On May 06, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from three studies will be featured at the American Urological Association annual meeting, which will take place May 6-10 in San Diego, Calif (Press release, Myriad Genetics, MAY 6, 2016, View Source [SID:1234512009]). Poster discussions include new data for the Prolaris test in patients with low-risk prostate cancer, as well as investigational molecular diagnostic tests for renal and bladder cancer.
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"Prolaris is the leading prognostic genetic test for patients with prostate cancer and is the only such test that predicts the 10-year risk of real oncologic outcomes including death, metastases and recurrence. The evidence in favor of genetic testing is expanding, and we’re excited to present a new analysis at AUA that further confirms the strong prognostic power of Prolaris in men with low-risk localized prostate cancer," said Michael Brawer, senior vice president of Medical Affairs, Myriad Genetic Laboratories. "We also are presenting new data for our investigational renal and bladder cancer tests, which further underscore Myriad’s commitment to developing pioneering molecular diagnostic tests for other urologic diseases."
Results of the studies to be presented are described below and abstracts are now available at: www.aua2016.org/abstracts/. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.
Highlighted Presentations
Title: The CCP score provides significant prognostic information in Gleason score <6 patients.
Date: Friday, May 6, 2016: 8:00—10:00 a.m. PT.
Location: Poster MP2.
Presenter: Jay Bishoff, M.D., Intermountain Urological Institute.
This meta-analysis of five studies evaluated the ability of the Prolaris test (CCP score) to predict oncologic outcomes (i.e., recurrence or death) in 440 patients with low-risk localized prostate cancer, which was defined as a Gleason score of 6 or less. The results showed that the Prolaris test is a significant predictor of oncologic outcomes in patients with low-risk disease (HR 1.5; p<0.009). Prolaris also was a better independent predictor of outcomes than traditional clinical features as measured by CAPRA (Cancer of the Prostate Risk Assessment; HR 1.27; p<0.03). When the Prolaris and CAPRA scores were assessed together, the combined clinical risk (CCR) score provided even greater predictive power (HR 1.83; p<0.0014). In this study, Prolaris was a strong predictor of the 10-year risk of oncologic outcomes in patients with localized prostate cancer and a Gleason score of 6 or less.
Title: A study to evaluate the prognostic and predictive utility of CCP and HRD assays and genetic sequencing in patients undergoing neoadjuvant chemotherapy in bladder cancer.
Date: Sunday, May 8, 2016: 1:00—3:00 p.m. PT.
Location: Poster MP49.
Presenter: Hristos Kaimakliotis, M.D., Indiana University.
This exploratory study evaluated three molecular assays to determine if they were able to predict response to neoadjuvant chemotherapy with cisplatin in patients with urothelial bladder cancer (UBC). The assays included 1) a cell cycle progression score, 2) the homologous recombination deficiency (HRD) score, and 3) genetic sequencing of a set of 80 genes associated with UBC. The results showed that RB1 mutations were associated with response to cisplatin neoadjuvant chemotherapy, and the predictive ability was improved by the addition of either the CCP or HRD scores. Additionally, HRD could be used to predict risk of disease recurrence in patients after neoadjuvant chemotherapy followed by cystectomy. If validated, these tests may help identify chemo-responsive patients.
Title: Prognostic utility of a multi-gene signature (the cell cycle proliferation score) in patients with renal cell carcinoma (RCC) after radical nephrectomy.
Date: Monday, May 9, 2016: 3:30—5:30 p.m. PT.
Location: Poster MP78.
Presenter: Adam Feldman, M.D., Massachusetts General Hospital.
The objective of this study was to assess the ability of the Myriad myPlan Renal Cancer cell cycle progression test to predict long-term oncologic outcomes in patients with surgically-resected renal cell carcinoma (RCC). Outcomes were defined as disease recurrence (local or metastatic) or disease-specific survival (DSS). Patient data were censored at five-years of follow-up. In the training cohort (N= 305), the myPlan Renal Cancer test was a significant prognostic predictor for recurrence (HR: 1.74; p = 0.02) and DSS (HR: 2.59; p< 0.001) after adjusting for clinical variables. The validation cohort (N=262) demonstrated a consistent and significant prediction of recurrence and DSS, with the strongest association being for DSS (HR: 2.2; p < 0.001) after adjusting for clinical variables. Based on these data, the myPlan Renal Cancer test appears to be a significant and independent predictor of key long-term oncologic outcomes in patients who have undergone nephrectomy for RCC, providing prognostic information beyond what is available from clinical parameters. Additional studies are underway to evaluate the utility of the score when derived from diagnostic biopsy.
About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.
About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information visit: www.myriad.com.
About Myriad myPlan Renal Cancer
Myriad myPlan Renal Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with renal cell carcinoma. For more information visit: View Source