Findings shared in an oral presentation at ASTRO Annual Meeting 2022 suggest predictive biomarker could help guide treatment in men experiencing disease progression after surgery

Veracyte, Inc. (Nasdaq: VCYT) announced new data demonstrating that a genomic signature derived from the company’s Decipher GRID database could help determine which men experiencing prostate cancer progression following radical prostatectomy (RP) would benefit from dose-intensified salvage radiotherapy (SRT). The data, from a randomized, phase 3 trial, were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 (abstract #160) taking place October 23-26, 2022, in San Antonio, Texas.

Post-Operative Radiation Therapy Outcomes Score (PORTOS) is a gene-expression signature of 24 DNA damage, repair and immune pathway genes previously shown to predict benefit from postoperative radiotherapy. In the current study, researchers evaluated the biomarker’s predictive ability for SRT dose among 226 men in the prospective open-label, multicenter, randomized phase 3 Swiss Group for Clinical Cancer Research (SAKK) 09/10 trial. This trial, which randomized men with biochemically recurrent disease after RP to conventional or dose-intensified salvage radiotherapy without the addition of androgen deprivation therapy (ADT), did not report a clinical benefit for dose-intensification.

The new data shared at ASTRO show that the subset of men with higher PORTOS scores had substantial improvement in clinical-progression-free survival (CPFS) with the higher dose of SRT (70Gy). Specifically, those men with higher PORTOS scores had an absolute benefit of 45% CPFS at 5 years with dose-intensified SRT compared with the standard dose, while the men with lower PORTOS scores had an absolute benefit of -10% (p-interaction=0.003).

“Our findings suggest that the Decipher PORTOS signature may be a valuable tool to help physicians better identify those prostate cancer patients who should receive dose-intensified salvage radiotherapy when their disease recurs following radical prostatectomy,” said Alan Dal Pra, M.D., member of Sylvester Comprehensive Cancer Center, director of Clinical Research and associate professor of radiation oncology at the University of Miami Miller School of Medicine, and lead author on the ASTRO abstract. “Dependent on further studies, this could be the first predictive biomarker to help physicians personalize radiotherapy dose in the postoperative prostate cancer setting.”

It is estimated that up to 40 percent of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen (PSA).¹ For those men who experience a rising PSA, treatment with 64-72 Gy SRT is now standard of care, though treatment with higher doses can lead to greater urinary and bowel side effects.

“This study demonstrates how gene-expression signatures can help identify the men who are most likely to benefit from more radiation, and help inform physician and patient decisions regarding their radiation treatment after surgery,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “We very much value our multi-year research efforts with the Swiss SAKK study group, and look forward to our continued collaborations with leading academic and industry partners to further validate GRID-derived predictive biomarkers that may help physicians better individualize the care of men with prostate cancer.”

About Decipher GRID

The Decipher Genomics Resource for Intelligent Discovery (GRID) database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its research partners to help advance understanding of prostate and other urologic cancers. PORTOS is among more than 400 biomarkers that have been discovered or developed using Decipher GRID and are available on a Research Use Only basis to physicians who have ordered the Decipher Prostate Genomic Classifier.

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. Examples of forward-looking statements include, among others, that the Decipher PORTOS signature may be a valuable tool to help physicians better identify those prostate cancer patients who should receive dose-intensified salvage radiotherapy when their disease recurs following radical prostatectomy, and that GRID-derived predictive biomarkers may help physicians better individualize the care of men with prostate cancer. 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.

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.

¹ Tourinho-Barbosa R, et al. Biochemical recurrence after radical prostatectomy: what does it mean? Int Braz J Urol. 2018 Jan-Feb;44(1):14-21. doi: 10.1590/S1677-5538.IBJU.2016.0656.

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