Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, has announced compelling new data from the phase 3 STAMPEDE clinical trial demonstrating that its Decipher Prostate Genomic Classifier predicts chemotherapy benefit in patients with metastatic prostate cancer. The findings, presented at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, support Veracyte’s plan to expand the use of its Decipher Prostate test to include patients with metastatic disease.

Key Findings from the STAMPEDE Trial

The Decipher Prostate test, already widely used to guide care for localized prostate cancer, has now shown prognostic value for clinical outcomes in patients with advanced or metastatic disease. The new data from the STAMPEDE trial, which followed 1,523 patients with advanced or metastatic prostate cancer for a median of 14 years, indicates that the test can help identify which patients will benefit most from the addition of the chemotherapy drug docetaxel to standard androgen deprivation therapy (ADT).

According to the study, higher Decipher Prostate scores were associated with an increased risk of death among all patients. However, among the 832 patients with metastatic disease, those with higher Decipher scores saw a 36% reduction in risk of death when treated with docetaxel in addition to ADT. In contrast, patients with lower Decipher scores did not experience a significant benefit from the addition of docetaxel.

Implications for Clinical Practice

The results are particularly significant because they suggest that the Decipher Prostate test could help guide the use of docetaxel in patients with metastatic prostate cancer, regardless of whether they have high- or low-volume disease. This challenges current clinical practices that favour using docetaxel primarily in patients with high-volume disease.

Dr. Gerhardt Attard, Professor and John Black Charitable Foundation Endowed Chair in Urological Cancer Research at University College London, and co-investigator in the STAMPEDE trial, commented: “Our findings are important because they show that the Decipher Prostate test can help clinicians better distinguish patients with metastatic prostate cancer who receive the greatest benefit from docetaxel from those who don’t and may therefore avoid unnecessary toxicity.”

Future Expansion and Reimbursement

Veracyte plans to make the Decipher Prostate test available to patients with metastatic prostate cancer by early 2025, pending expected reimbursement by Medicare. Recently, MolDX, a program that establishes Medicare coverage for advanced molecular diagnostic tests, issued a local coverage determination for molecular testing in patients with metastatic prostate cancer. This development provides a pathway to coverage for the Decipher Prostate test.

Marc Stapley, Veracyte’s chief executive officer, expressed enthusiasm about the new data and the broader potential of their diagnostic platform: “These important advances clearly demonstrate the power of our Veracyte Diagnostics Platform, which delivers high-performing cancer tests and a powerful evidence-generation engine. Ultimately, this novel approach helps drive widespread test reimbursement and adoption, along with new insights to support our pipeline.”

The Decipher Prostate Genomic Classifier is a 22-gene test developed using RNA whole-transcriptome analysis and machine learning. It helps inform treatment decisions for prostate cancer patients by predicting the risk of developing metastasis with standard treatment. The test’s utility has been validated in more than 80 published studies involving over 100,000 patients, achieving ‘Level 1B’ evidence status in the most recent National Comprehensive Cancer Network (NCCN) Guidelines for prostate cancer.

The new findings presented at ESMO 2024 underscore the Decipher Prostate test’s potential to improve personalised treatment strategies for patients with metastatic prostate cancer. As Veracyte continues to expand the scope of this test, it could significantly impact how clinicians manage prostate cancer across different stages of the disease.

  chemotherapy benefit, Decipher Prostate test, docetaxel, metastatic prostate cancer, STAMPEDE trial, Veracyte