New Data Validate Clinical Utility of Veracyte’s Decipher Prostate Genomic Classifier To Help Guide Therapy In Men with Intermediate-Risk Prostate Cancer

Findings shared at 2022 ASCO GU Symposium are from the first late-stage clinical study validating any gene-expression test for this patient group

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced that new data validating the clinical utility of the company’s Decipher Prostate Genomic Classifier for guiding treatment selection in men with intermediate-risk prostate cancer will be presented Thursday, February 17, at the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Symposium (Poster #M1). The data, from the randomized, Phase 3 NRG/RTOG 0126 study, confirm initial findings that the Decipher Prostate Genomic Classifier is a prognostic biomarker that can help physicians and patients make personalized treatment decisions in the intermediate-risk setting.

“These findings represent the first high-level evidence of any genomic classifier in intermediate-risk prostate cancer and demonstrate that the Decipher 22-gene biomarker significantly improves prognostic performance across numerous clinically meaningful endpoints,” said Daniel Spratt, M.D., chair of Radiation Oncology at University Hospitals Seidman Cancer Center and professor and chair of the Department of Radiation Oncology at Case Western Reserve University School of Medicine, and lead investigator for the study.

Prostate cancer deemed “intermediate risk” by the National Comprehensive Cancer Network (NCCN) Guidelines® for Prostate Cancer is the most heterogenous of all risk groups in prostate cancer, and there are a wide variety of treatment options available. The Decipher Prostate Genomic Classifier is a prognostic biomarker that provides additional information about the aggressiveness of individual patients’ cancer to help physicians more accurately categorize their risk and select appropriate treatments. The study conducted by Dr. Spratt and colleagues confirms findings from prior Phase 2 studies and validates for the first time the test’s performance in men with intermediate-risk disease using multi-center Phase 3 trial data.

To assess the prognostic performance of the Decipher Prostate test in the intermediate-risk, post-biopsy setting, researchers utilized patient biopsy samples from the phase 3, randomized NRG/RTOG 0126 trial. This study enrolled men with intermediate-risk prostate cancer, and then compared clinical outcomes following randomization to two different doses of radiation therapy (70.2 Gy vs 79.2 Gy) without hormone therapy. Researchers generated classifier data for each of 215 biopsy samples, then linked the data with clinical outcomes assessing multiple oncologic and survival endpoints. Patients were followed for a median of 12.8 years.

The findings, which will be presented for the first time at ASCO GU this week, show that the Decipher Prostate test was independently prognostic for all clinical endpoints, including disease progression (sub-distribution hazard ratio [sHR] 1.12, 95%CI 1.0-1.26, p=0.04), biochemical failure (sHR 1.22, 95%CI 1.1-1.37, p