New Data Published in JAMA Oncology Demonstrate Prognostic Utility of Veracyte’s Decipher Prostate Genomic Classifier in Locally Advanced Prostate Cancer
First study demonstrating Decipher Prostate test can inform treatment decisions in nmCRPC
“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
The Decipher Prostate genomic classifier is currently being investigated in seven
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.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) regarding the Decipher Prostate Genomic Classifier’s ability to provide prognostic information that can help physicians tailor treatment decisions for men with prostate cancer. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," “suggest,” "may," "will" and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: Veracyte’s ability to achieve and maintain Medicare coverage for its tests; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the
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