New data are from a retrospective analysis of the Phase 2 STREAM trial

Veracyte, Inc. (Nasdaq: VCYT) announced that new data published in JCO Precision Oncology suggest that gene expression signatures derived from the company’s Decipher Genomics Resource for Intelligent Discovery (GRID) database may help advance understanding of the genomic drivers impacting patient response to treatment for recurrent prostate cancer. The findings, from the Phase 2 STREAM study, suggest the potential to use transcriptomic signatures to identify patients in this setting who may benefit from more intensive salvage therapy as well as those who may need alternative care such as chemotherapy.

“The STREAM study showed that, despite treatment with six months of androgen deprivation therapy and enzalutamide, nearly 50% of patients receiving radiation therapy for prostate cancer that has returned experience relapse within three years,” said Andrew Armstrong, M.D., ScM, professor of Medicine and director of Research, Duke Cancer Institute Center for Prostate and Urologic Cancers, and senior/corresponding author for the manuscript. “Using the Decipher GRID database, we found that men in the STREAM study with luminal differentiated genotypes had excellent outcomes, while those whose tumors had a basal, luminal proliferating genotype or other specific genomic characteristics such as PTEN loss had a higher risk of recurrence despite these therapies.”

The three-center, prospective Phase 2 STREAM study was led by Dr. Armstrong and Duke University colleague Rhonda L. Bitting, M.D. The trial evaluated the safety and efficacy of adding six months of enzalutamide to androgen deprivation therapy (ADT) and salvage radiotherapy in patients with rising prostate-specific antigen (PSA) following radical prostatectomy and radiotherapy (RT). A previous publication demonstrated that 51% of men remained free of disease at three years following treatment.

Using prostatectomy tissue from 31 study participants, all of whom had NCCN intermediate- (12.9%) or high-risk (87.1%) disease, researchers conducted a retrospective analysis using the Decipher GRID database to determine whether specific genomic signatures could help predict which patients would benefit from the aggressive therapy regimen, and which may require additional or alternative care.

Results suggest that patients in the study who experienced shorter progression-free survival (PFS) over three years had a luminal proliferating tumor subtype, loss of the PTEN gene and/or higher homologous recombination deficiency (HRD) signature scores. Patients with luminal differentiated or luminal A-type tumors and/or higher postoperative ADT responsiveness genomic signature scores were more likely to have durable responses and long-term remissions with the aggressive systemic regimen of ADT and enzalutamide combined with salvage radiotherapy.

“This study provides further evidence that the Decipher GRID database is a valuable tool to help researchers better understand the specific genomic signatures and factors that impact prostate cancer disease progression and individual responses to various treatment approaches,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.

The Decipher GRID database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic, and treatment decisions for some of the most challenging diseases such as thyroid, prostate, breast, bladder and lung cancers, as well as interstitial lung diseases. We help patients avoid unnecessary procedures and speed time to diagnosis and appropriate treatment. In addition to making our tests available in the U.S. through our central laboratories, we also aim to deliver our tests to patients worldwide through a distributed model to 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. Examples of forward-looking statements include, among others, that the Decipher GRID database may help advance understanding of the genomic drivers impacting patients’ response to treatment for recurrent prostate cancer, and that it may ultimately help inform more personalized treatment for patients with recurrent disease. 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 22, 2023, and our Quarterly Report on Form 10-Q filed for the three months ended August 9, 2023. Copies of these documents, when available, may be found in the Investors section of our website at https://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.

Decipher Prostate is available in the US as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA. The Decipher GRID database is For Research Use Only - Not for use in diagnostic procedures / Not for use to support treatment decision.

Veracyte, the Veracyte logo and Decipher are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries.

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