ENZAMET Trial Shows Veracyte's Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced results from the ENZAMET trial presented at the 2026 ASCO Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B ¹ evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate's clinical utility in high-risk localized disease.

“For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator

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Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.^{2, 3} While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

“For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. "Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer.”

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

• Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
• Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
• Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test's predictive value.
• Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.

Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO 2026 adds to Decipher Prostate's growing body of evidence into high-risk localized prostate cancer.

Key findings include:

• Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
• Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
• Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.

"Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease," said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. "For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork."

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company with a vision to transform cancer care for patients around the world. The company’s molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and AI, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma® Genomic Sequencing Classifier test, Decipher® Bladder Genomic Classifier test, Decipher® Prostate Genomic Classifier test, Prosigna® Breast Risk of Recurrence test, and the TrueMRD™ Monitoring Test for MIBC. For more information, visit Veracyte’s website or follow the company on LinkedIn or X (Twitter).

About ANZUP

ANZUP is the leading cancer-cooperative clinical trials group that brings together all of the professional disciplines and groups involved in researching and treating urogenital cancers and conduct high quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to statements regarding the potential clinical utility and benefits of Veracyte’s Decipher Prostate Test; the ability of Decipher Prostate to identify patients with metastatic prostate cancer who may benefit from treatment intensification, and those who may safely avoid such treatment; the extent to which results from the ENZAMET trial and other studies may influence clinical decision-making; the predictive and prognostic performance of Decipher Prostate across the prostate cancer continuum; and the adoption and use of Decipher Prostate in clinical practice. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” "ultimately," 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. 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 on February 26, 2026, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

References:

1. Simon, R. M., Paik, S. & Hayes, D. F. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 101, 1446–1452 (2009). https://doi.org/10.1093/jnci/djp335
2. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
3. https://www.cdc.gov/united-states-cancer-statistics/publications/prostate-cancer.html