Veracyte announces new data from Phase 3 STAMPEDE clinical trial

Veracyte announced that new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial show that its Decipher Prostate Genomic Classifier is prognostic for clinical outcomes and predicts benefit from docetaxel in patients with metastatic prostate cancer. The findings were presented at the European Society for Medical Oncology 2024 Congress in Barcelona. These findings support Veracyte’s plan to expand use of the Decipher Prostate test – currently widely used to guide care for localized prostate cancer – to patients with metastatic disease. Prostate cancer accounts for a fifth of all male cancer-related deaths globally and the number is expected to double over the next two decades. In the United States, it is the second-leading cause of cancer deaths among men, with more than 35,000 men expected to die of the disease in 2025.2 Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease. In the new study, researchers analyzed data for 1,523 patients with advanced or metastatic prostate cancer who were followed in the STAMPEDE trial for a median of 14 years. They found that higher Decipher Prostate test scores were associated with an increased risk of death in both groups. Additionally, among the 832 patients with metastatic disease, only those with higher Decipher Prostate scores received a significant survival benefit from the addition of docetaxel to ADT. These patients had a 36% reduction in risk of death with the addition of docetaxel as compared to those with lower Decipher scores who did not significantly benefit. Notably, docetaxel was beneficial in patients with higher Decipher Prostate scores regardless of whether they had high- or low-volume prostate cancer. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease. Veracyte expects to begin offering the Decipher Prostate test to patients with metastatic prostate cancer in early 2025, after its anticipated reimbursement by Medicare. MolDX, a program that establishes Medicare coverage for advanced molecular diagnostic tests, recently issued a local coverage determination for molecular testing in patients with metastatic prostate cancer, providing what Veracyte believes is a pathway to coverage for its test.