On June 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data demonstrating the prognostic utility of the company’s Decipher Prostate genomic classifier among men with non-metastatic castration-resistant prostate cancer (nmCRPC) have been published online in JAMA Oncology (Press release, Veracyte, JUN 14, 2021, View Source [SID1234583964]). The findings, from a retrospective analysis of patients in the Phase 3 SPARTAN study, suggest that the Decipher test can help identify those patients most likely to benefit from treatment with apalutamide, a second-generation androgen receptor signaling inhibitor (ARSi), in addition to androgen-deprivation therapy (ADT).
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"These results suggest that the Decipher Prostate test may be a helpful tool to identify those patients who would benefit from early treatment intensification with androgen receptor inhibitors," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, Scientific and Clinical Operations, Urologic Cancers. "As the first clinical evaluation and demonstration of the Decipher test’s utility in the nmCRPC setting, this study adds meaningfully to prior evidence demonstrating the test’s ability to help inform treatment decisions and improve patient outcomes in multiple prostate cancer settings."
SPARTAN is a multicenter, international, randomized, double-blind, placebo-controlled, Phase 3 trial that investigated the efficacy of adding apalutamide to androgen-deprivation therapy (ADT) in comparison with ADT plus placebo among men with nmCRPC. Results from the trial suggest that the addition of apalutamide to ADT significantly improved metastasis free survival (MFS) and other secondary endpoints in these men.
To understand the molecular characteristics driving the SPARTAN study clinical outcomes, researchers used the Decipher genomic classifier to perform gene expression profiling on archived primary tumor samples from a subset of 233 patients enrolled in the trial. The test stratified patient tumors into Decipher high- and low-to-average-risk groups for metastasis and into basal and luminal subtypes.
The newly published results suggest that Decipher test scores and basal-luminal subtype may be biomarkers of response to apalutamide plus ADT in the nmCRPC setting, and that patients whose tumors were classified as Decipher high-risk or luminal subtype derive the greatest benefit from apalutamide therapy.
Specifically, while study results indicate an MFS improvement among all nmCRPC patients who received apalutamide plus ADT, the 116 patients in the subset who had Decipher high-risk scores exhibited the greatest improvement in MFS (HR 0.21; 95% CI, o.11-0.40; P<0.001) and progression-free survival 2 (PFS2; HR, 0.39; 95% CI, 0.23-0.67; P = 0.001) vs. placebo plus ADT. Notably, the addition of apalutamide to ADT improved the MFS percentage among the Decipher high-risk patients to a level similar to the percentage among patients classified as Decipher low-to-average-risk.
Also, among the apalutamide plus ADT group, those patients whose tumors had the luminal subtype (n=81) experienced a significantly longer MFS compared to those with the basal subtype (n=152; median MFS not reached; HR, 0.40; 95% CI, 0.38-1.60; P=0.50).
Researchers noted that Decipher testing was conducted on samples taken from ADT-naïve patients an average of 6.7 years prior to their enrollment in the SPARTAN study. This suggests that the molecular signatures in initial diagnostic samples taken from primary tumors can be informative for making treatment decisions years later when the cancer has locally advanced.
"These findings are an important addition to our growing understanding about how best to manage patients across the long trajectory of prostate cancer," said Felix Y. Feng, MD, professor of Radiation Oncology, Urology, and Medicine, and vice chair for Translational Research, Department of Radiation Oncology at the University of California, San Francisco, who is a SPARTAN study investigator and the paper’s primary author. "They suggest that genomic testing provides useful information to guide treatment decisions that may improve outcomes among men with locally advanced disease, a population for which we’ve previously lacked genomic biomarkers."
The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.
About Decipher Prostate
Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.