New Data Published in JAMA Oncology Demonstrate Prognostic Utility of Veracyte’s Decipher Prostate Genomic Classifier in Locally Advanced Prostate Cancer

Veracyte, Inc. (Nasdaq: VCYT) today announced 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. 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).

“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.