Veracyte's Decipher Prostate Test Predicts Chemotherapy Benefit in Metastatic Prostate Cancer

Veracyte, Inc. (Nasdaq: VCYT), a prominent company in cancer diagnostics, has unveiled new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial. The findings indicate that the Decipher Prostate Genomic Classifier is prognostic for clinical outcomes and can predict the benefit of docetaxel treatment in patients with metastatic prostate cancer. These results were shared at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona. The new data bolster Veracyte's intention to extend the use of the Decipher Prostate test, which is currently used extensively for managing localized prostate cancer, to those with metastatic conditions.

Prostate cancer is responsible for a significant portion of male cancer-related deaths worldwide, accounting for about 375,000 deaths annually. This figure is predicted to double in the next two decades. In the United States, prostate cancer is the second leading cause of cancer deaths among men, with over 35,000 fatalities expected by 2025. Most of these deaths are among patients initially diagnosed with advanced or metastatic prostate cancer.

Combining docetaxel chemotherapy with androgen deprivation therapy (ADT) can enhance survival in patients with metastatic prostate cancer. However, the response to docetaxel varies among patients, and current tools are insufficient for predicting who will benefit from this treatment. According to Dr. Gerhardt Attard, a professor at University College London and co-investigator of the STAMPEDE trial, the Decipher Prostate test could aid clinicians in identifying patients who are most likely to benefit from docetaxel, thereby preventing unnecessary exposure to its toxic effects.

The study analyzed data from 1,523 patients with advanced or metastatic prostate cancer, tracked over a median of 14 years in the STAMPEDE trial. Findings revealed that higher Decipher Prostate test scores were linked to an increased risk of death in all patient groups. Among the 832 patients with metastatic disease, those with higher Decipher scores who received docetaxel in addition to ADT experienced a significant survival benefit, with a 36% reduction in death risk. In contrast, patients with lower Decipher scores did not show a significant benefit from the addition of docetaxel.

Importantly, the benefit of docetaxel was evident in patients with higher Decipher Prostate scores regardless of their disease volume. This contrasts with current clinical practices, which prefer using docetaxel for high-volume disease. Elai Davicioni, Ph.D., Veracyte's medical director for Urology, emphasized that the Decipher Prostate test is already well-regarded for guiding treatment in localized prostate cancer. The new phase 3 data from the STAMPEDE trial further validate its effectiveness for metastatic prostate cancer, potentially making a significant positive impact on patient care.

Veracyte plans to offer the Decipher Prostate test to patients with metastatic prostate cancer by early 2025, following anticipated reimbursement by Medicare. MolDX, a program that establishes Medicare coverage for advanced molecular diagnostic tests, has recently issued a local coverage determination for molecular testing in patients with metastatic prostate cancer, which Veracyte believes paves the way for its test's coverage.

Marc Stapley, CEO of Veracyte, expressed excitement about the new data presented at ESMO and the opportunity to improve cancer care for a broader patient population. He highlighted that the Veracyte Diagnostics Platform, which produces high-performing cancer tests and generates robust evidence, supports widespread test reimbursement and adoption. This approach reinforces the expansion of Decipher Prostate use across the prostate cancer continuum, benefiting both low-risk patients who might opt for active surveillance and those with metastatic disease who could benefit from chemotherapy.