Findings from ancillary study of Phase 3 STAMPEDE trial reveal Decipher Prostate test is prognostic for clinical outcomes in men with high-risk non-metastatic and metastatic prostate cancer

Data support Veracyte’s plan to expand test availability in the U.S. and offer test globally as an in vitro diagnostic

Veracyte, Inc. (Nasdaq: VCYT) announced that new data from a Phase 3 trial of the multi-center, multi-national, randomized STAMPEDE platform protocol confirm the ability of the company’s Decipher Prostate Genomic Classifier to identify men with advanced prostate cancer who are more likely to benefit from intensified treatment with abiraterone acetate and prednisolone (AAP) in addition to standard-of-care androgen-deprivation therapy (Abstract #13580). The findings were shared in an oral presentation today at the European Society for Medical Oncology (ESMO) Congress 2022 and support the company’s continued expansion of its high-value genomic tests for patients in the United States and globally.

“There are an increasing number of treatment options available for men with advanced prostate cancer, and the challenge for physicians is determining the best treatment combination for the right patient,” said Gerhardt Attard, M.D., Ph.D., group leader of the Treatment Resistance Research Group at the University College London Cancer Institute, and STAMPEDE study co-investigator. “Our findings show that the Decipher Prostate Genomic Classifier – and tumor transcriptomes in general – can provide robust and clinically relevant prognostic information that may help guide important decisions about the treatment of advanced prostate cancer. Most notably, this study has identified patients who have poor prognoses and benefit greatly from addition of hormone treatment tablets, while other men have a good prognosis and may be able to avoid the toxicities of treatment.”

The Decipher Prostate classifier is a 22-gene prognostic biomarker that provides a score that indicates the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

The STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) protocol involves more than 10,000 men to date with high-risk, non-metastatic (M0) or metastatic (M1) prostate cancer who are starting long-term androgen-deprivation therapy (ADT) for the first time and are randomized to new treatments in (to date) seven Phase 3 trials. In this post-hoc analysis of the abiraterone acetate trial, Prof. Attard and colleagues evaluated the prognostic ability of the Decipher Prostate test among 781 men who were randomized to receive standard-of-care ADT with or without abiraterone acetate and prednisolone (AAP). They found that Decipher was prognostic in both the M0 and M1 patients, with higher Decipher scores associated with worse overall survival in M1 patients, and worse metastasis-free survival in M0 patients. Additionally, study findings suggest that men with high Decipher scores who received AAP had the greatest improvement in outcomes, while those with low Decipher scores received less absolute oncologic benefit from the addition of AAP.

“The Decipher Prostate classifier is the most validated genomic test in prostate cancer, and this analysis suggests that we may be able to further expand its use to help inform often-challenging decisions regarding intensification of therapy in men with advanced prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. “We are honored to be working with leading prostate cancer researchers around the world to help further advance precision medicine.”

“These findings, from one of the most important prostate cancer clinical trials of this era, further underscore our commitment to clinical rigor and innovation in our efforts to improve patient outcomes in prostate and other cancers,” said Marc Stapley, Veracyte’s CEO. “They also further support our plan to deliver our high-value tests, including the Decipher Prostate Genomic Classifier, to patients around the world.”

Among the other abstracts presented at the ESMO conference, researchers shared data derived from Veracyte’s Decipher GRID, a database of more than 100,000 whole-transcriptome profiles from patients with urologic cancers. Decipher GRID has led to the discovery or development of more than 400 genomic signatures that can be leveraged to help advance understanding of prostate and other urologic cancers, as well as to support biopharmaceutical companies’ targeted-therapy development programs.

In a poster presentation today (Abstract #1381P), researchers shared data showing that the Decipher GRID androgen receptor activity (AR-A) signature is prognostic for outcomes in men with castration-sensitive prostate cancer (CSPC) that has spread to no more than three other sites in the body (oligometastatic CSPC, or omCSPC). The researchers concluded that the GRID AR-A signature is prognostic for outcomes in men with omCSPC treated with metastasis-directed therapy (MDT, or radiotherapy) and that patients with a low AR-A score receive the most benefit from the addition of ADT to MDT.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company that improves patient care by answering important clinical questions to inform diagnosis and treatment decisions. Our growing menu of advanced diagnostic tests help patients avoid risky, costly procedures and interventions, and reduce time to appropriate treatment. In addition to making our tests available in the United States through our central laboratories, our exclusive license to our best-in-class diagnostics instrument (nCounter Analysis System) positions us to deliver our tests to patients worldwide through laboratories that can perform them locally. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to our clinical tests in and outside of the United States. Forward-looking statements can be identified by words such as: “appears,” "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will," “positioned,” “designed” and similar references to future periods. An example of a forward-looking statements include, among others, that data presented at the ESMO Congress may help expand availability of our Decipher Prostate Genomic Classifier and that the Decipher Prostate Genomic Classifier may help to identify men with advanced prostate cancer who are more likely to benefit from intensified treatment. 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 28, 2022, and our Quarterly Report on Form 10-Q to be filed for the three months ended June 30, 2022. Copies of these documents, when available, may be found in the Investors section of our website at www.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.

Veracyte, the Veracyte logo and Decipher are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries. nCounter is the registered trademark of NanoString Technologies used by Veracyte under license.

Veracyte delivers the Decipher Prostate Genomic Classifier from its CLIA laboratories. Those tests are not CE-IVD marked and have not been cleared or approved by the FDA; their performance characteristics were determined by Veracyte and they might be considered for Research Use Only in some markets. Please contact Veracyte for confirmation. This piece is distributed purely for educational purposes and is not intended to promote or encourage any off-label use of Veracyte products.

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