New Data Demonstrate Clinical Utility of Veracyte’s Decipher Prostate Genomic Classifier in Tailoring Treatment for Prostate Cancer Patients Experiencing Progression After Surgery

Rhea-AI Summary

Veracyte (NASDAQ: VCYT) presented new data at the ASTRO Annual Meeting 2021, indicating that its Decipher Prostate genomic classifier is effective in tailoring treatment for men with prostate cancer after radical prostatectomy. Results from a phase 3 trial involving 226 patients showed that those classified as high-risk using the Decipher tool had over double the likelihood of experiencing cancer progression with radiotherapy alone. This study highlights the potential for personalized treatment plans, enhancing outcomes for patients with rising PSA levels.

Positive

• Decipher Prostate genomic classifier shows promise in personalizing treatment for prostate cancer.
• High-risk patients identified by Decipher have targeted interventions, potentially improving outcomes.

Negative

• Study indicates nearly 90% recurrence risk for high-risk patients receiving radiotherapy alone.
• Significant decision-making complexity remains for timing and intensity of treatments.

Findings shared today in an oral presentation at ASTRO Annual Meeting 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced new data demonstrating the clinical utility of the company’s Decipher Prostate genomic classifier for guiding the timing and intensity of treatment in men experiencing prostate cancer progression following radical prostatectomy. The data, from a randomized, phase 3 trial conducted at 24 centers in Belgium, Germany, and Switzerland (SAKK 09/10), were presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 (abstract #94).

Following radical prostatectomy, physicians typically monitor prostate cancer patients’ prostate-specific antigen (PSA) to identify biochemical recurrence. For those men who experience a subsequent rise in PSA, determining the optimal timing to initiate treatment and whether to add androgen deprivation therapy (ADT) to radiotherapy is challenging. Conventional clinical measures such as PSA and pathological findings following surgery are often insufficient to predict which patients will experience favorable oncologic outcomes with radiotherapy alone, and which will have disease that continues to progress.

To determine whether the Decipher Prostate genomic classifier could help identify those patients who would benefit from earlier intervention with radiotherapy or the addition of ADT to radiotherapy in this setting, researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 phase 3 randomized clinical trial. This study involved men experiencing a rise in PSA following radical prostatectomy, all of whom received radiotherapy without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

“We’re pleased to have participated in this study, which explored a critical decision point in the management of men with prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s senior vice president of Scientific and Clinical Operations, Urologic Cancers. “The side effects of ADT when given concurrently with radiotherapy are often difficult for patients to manage. Being able to identify those patients who are likely to have favorable outcomes with radiotherapy alone, as well as the men who would benefit most from adding ADT to radiotherapy, could significantly improve the management of men with biochemically recurrent prostate cancer.”

The data shared at ASTRO today show that men with disease classified as Decipher high-risk were more than twice as likely as those whose disease was classified as Decipher low/intermediate-risk to experience biochemical and clinical progression with radiotherapy alone. Additionally, Decipher high-risk patients with PSA levels above 0.5 ng/mL who received radiotherapy alone had a nearly 90% risk of cancer recurrence in the five years following treatment.

“The results of our study suggest that men with higher Decipher Prostate scores should be considered for earlier intervention when experiencing a rise in PSA, and depending on PSA level at time of treatment, these men may receive the most benefit from the addition of ADT to radiotherapy,” said Alan Dal Pra, M.D., director of Clinical Research at Sylvester Comprehensive Cancer Center, associate professor of radiation oncology at the University of Miami Miller School of Medicine, and lead author on the ASTRO abstract. “This type of genomic, risk-based approach can support more informed, individualized treatment planning.”

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of diagnostic tests leverages advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer, colon cancer, and idiopathic pulmonary fibrosis are available to patients and its renal cancer and lymphoma subtyping tests are in development, the latter as a companion diagnostic. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its genomic tests to patients worldwide. 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 the Decipher Prostate genomic classifier. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," “suggest,” "may," "will" “prospective” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that its Decipher Prostate genomic classifier can help guide the timing and intensity of treatment among 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 with the SEC on February 22, 2021 and our subsequent quarterly reports on Form 10-Q. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, Veracyte specifically disclaims 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, HalioDx, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its affiliates in the U.S. and selected countries. nCounter is the registered trademark of NanoString Technologies, Inc. in the U.S. and selected countries and used by Veracyte under license.

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Investor and Media Contact:

Tracy Morris

Vice President of Corporate Communications & Investor Relations

tracy.morris@veracyte.com

650-380-4413

Source: Veracyte, Inc.

FAQ

What are the key findings from Veracyte's Decipher study presented at ASTRO 2021?

The study found that high-risk patients using the Decipher Prostate genomic classifier have a much higher risk of cancer progression with radiotherapy alone.

How does the Decipher Prostate genomic classifier assist prostate cancer treatment?

It helps identify patients who may benefit from earlier treatment interventions, enhancing personalized treatment planning.

What is the risk of recurrence for high-risk patients in the study?

High-risk patients with PSA levels above 0.5 ng/mL had nearly a 90% risk of cancer recurrence in five years after treatment.

Who conducted the phase 3 trial of the Decipher Prostate genomic classifier?

The trial was conducted by the Swiss Group for Clinical Cancer Research (SAKK) across 24 centers in Belgium, Germany, and Switzerland.

What is the significance of the findings for prostate cancer management?

These findings promote a genomic, risk-based approach to treatment, aiming for more informed, individualized patient care.