SALT LAKE CITY, Utah, March 3, 2014 – Myriad Genetics, Inc. (Nasdaq: MYGN) today announced that it has published data from the PROCEDE 500 study in the journal Current Medical Research and Opinion, demonstrating that 65 percent of physicians changed their original treatment plans for men with prostate cancer based on results from the Prolaris test. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in 11 clinical studies with more than 5,000 patients.
"Prolaris is an absolute game changer for urologists because it adds meaningful new prognostic information in terms of risk assessment for prostate cancer patients that will improve their care," said E. David Crawford, M.D., head of the Section of Urologic Oncology at the University of Colorado. "In this study, Prolaris led to major changes in therapies with significant reductions or increases in interventional treatments that were based on patients' unique risk profiles."
PROCEDE 500 is a prospective registry study that was designed to evaluate the impact of the Prolaris test on physician treatment recommendations for patients with prostate cancer. In this study of 305 patients, physicians said they would change their treatment plans in 65 percent of cases after receiving the Prolaris report – 40 percent of patients had a reduction in therapeutic burden, while 25 percent had an increase in therapeutic burden – independent of treatment strategy (i.e., surgery and/or radiation vs. active surveillance and/or watchful waiting). These results are summarized in Table-1 and Table-2 below:
Table – 1: Reduction in Therapeutic Burden Among Trial Participants
Number of Patients in the StudyNumber of Patients Who Saw a Reduction in Therapeutic BurdenPercentageDecrease in Therapeutic Burden305122-40%
Table – 2: Increase in Therapeutic Burden Among Trial Participants
Number of Patients in the StudyNumber of Patients Who Saw an Increase in Therapeutic BurdenPercentageIncrease in Therapeutic Burden30576+25%
The study also evaluated the shift in treatment paradigms from interventional to non-interventional and non-interventional to interventional. Those data appear in the Table-3 and Table-4 below:
Table – 3: Planned Interventional Therapy (e.g., Surgery and/or Radiation)
Number of Patients Plannedfor Interventional TreatmentBefore Prolaris Test Score Number of Patients Plannedfor Interventional TreatmentAfter Prolaris Test Score PercentageDecrease in Interventional Therapy164103-37%
Table – 4: Planned Non-Interventional Therapy (e.g., Active Surveillance and/or Watchful Waiting)
Number of Patients Plannedfor Non-Interventional TreatmentBefore Prolaris Test Score Number of Patients Plannedfor Non-Interventional TreatmentAfter Prolaris Test Score1 PercentageIncrease in Interventional Therapy141108+23%
Importantly, in this study there was an overall 50 percent reduction in surgical interventions and a 30 percent reduction in radiation treatment. Additionally, 96 percent of the 24 patients with initial "undecided" treatment regimens selected non-interventional options after receiving the Prolaris score. These results demonstrate that the Prolaris test is associated with high clinical utility among urologists.
"In multiple clinical studies, Prolaris was shown to provide personalized risk of cancer-specific death, metastases or biochemical failure beyond what is achievable with the Gleason score, clinical stage and PSA data," said Michael Brawer, M.D. vice president of Medical Affairs at Myriad Genetic Laboratories. "PROCEDE 500 demonstrates that the Prolaris score significantly enhances treatment plans for men with localized prostate cancer."
Myriad Submits Updated Clinical Dossier for Medicare Reimbursement Myriad also announced that it has submitted the PROCEDE 500 data as part of the Prolaris clinical dossier to the Centers for Medicare & Medicaid Services (CMS) for Medicare reimbursement. As previously disclosed – based on the robust data set from 11 studies with more than 5,000 patients and six publications in peer-reviewed medical journals – the company expects a CMS coverage determination on Prolaris by the end of June 2014.
"More than 30,000 men will die from prostate cancer this year, so there is an urgent need to improve clinical care for patients," said Brawer. "Prolaris adds real value to the healthcare system by reducing unnecessary surgeries or exposure to radiation for men at low risk, while increasing medical interventions for men with aggressive prostate cancer, which we believe will save and improve more lives and potentially save the healthcare system more money."
Source: Myriad Genetics, Inc.