OPTIMA Trial Results to Be Presented at ASCO Provide New Evidence Supporting Prosigna-Guided Chemotherapy Decisions in Breast Cancer

Key Terms

phase iii medical

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

randomized trial medical

A randomized trial is a study where participants are assigned by chance—like flipping a coin—to different treatments or to a comparison group so the results reflect the effect of the treatment rather than other factors. Investors care because these trials provide the most reliable evidence about whether a drug, device, or strategy works, and strong, clear results can change a company’s approval prospects, market size and risk profile quickly.

non-inferiority trial medical

A non-inferiority trial is a clinical study designed to show that a new treatment or drug is not meaningfully worse than an existing standard therapy by a pre-set amount. For investors, these trials matter because they can enable regulatory approval and market entry when a new product offers similar benefit with other advantages (lower cost, easier use, fewer side effects); think of it like proving a new smartphone’s battery lasts nearly as long as the market leader so buyers will consider it.

androgen deprivation therapy medical

Androgen deprivation therapy is a medical treatment that lowers or blocks male hormones (androgens) to slow the growth of hormone-sensitive cancers, most commonly prostate cancer. Think of it as cutting off the fuel a fire needs so the blaze slows; for investors, changes in ADT use, new ADT drugs, or clinical trial results can affect demand for medications, device procedures, safety profiles and long-term revenue for healthcare companies.

enzalutamide medical

Enzalutamide is an oral prescription drug used to treat prostate cancer by blocking the male hormone signal that fuels tumor growth—think of it as a lock that stops the cancer’s hormonal “key” from turning. It matters to investors because regulatory approvals, patent protection, clinical safety and effectiveness data, and competing therapies directly influence the drug’s sales potential and therefore the financial prospects of companies that develop, market, or hold rights to it.

docetaxel medical

A chemotherapy medicine that works by stopping cancer cells from dividing and growing, often used to treat several solid tumors. Investors care because its sales, patent status, approval or label changes, and trial results can significantly affect drugmakers’ revenue and stock value—similar to how a single bestselling product can move a company’s fortunes when customer demand or regulations change.

genomic classifier medical

A genomic classifier is a medical test that reads patterns in a person’s genes to predict how a disease will behave or which treatments are most likely to work. For investors, it matters because these tests can change which drugs are used, speed up clinical decisions, influence health care costs and reimbursement, and create market opportunities or risks depending on clinical value, regulatory approval and adoption — like a weather forecast helping planners decide which storm preparations to make.

nccn risk reclassification medical

NCCN risk reclassification describes when a patient's cancer risk level is changed under guidelines from the National Comprehensive Cancer Network after new test results or clinical information. It matters to investors because a higher or lower risk category can change treatment choices, the use of diagnostic tests, drug prescriptions, and reimbursement patterns—similar to how a new weather forecast can shift what supplies people buy and how businesses respond.

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Additional Data from ENZAMET Study Show How Decipher Can Help Metastatic Prostate Cancer Patients Avoid Unnecessary Treatment and Enable More Personalized Care

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (NASDAQ: VCYT), a leading cancer diagnostics company, announced today that data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests will be presented at the 2026 ASCO Annual Meeting in Chicago, taking place May 29 – June 2. The OPTIMA and ENZAMET trial presentations are expected to provide practice-changing evidence demonstrating how Veracyte’s genomic tests can guide treatment decisions in both early-stage breast cancer and metastatic prostate cancer.

The OPTIMA study is a prospective, randomized trial led by University College London (UCL) and supported by the National Institute for Health Research (NIHR). The study enrolled more than 4,400 patients and was designed to address a key clinical question: which patients would benefit from chemotherapy, and which may be able to safely avoid it, and its long-term toxicities. The study results demonstrating how the Prosigna test can guide adjuvant chemotherapy decisions in patients with high-risk breast cancer will be presented by Dr. Rob Stein of UCL and OPTIMA Trial Chief Investigator, on Saturday, May 30 during the breast cancer session.

"The OPTIMA trial results represent a major milestone in precision breast oncology and will provide Level 1A evidence supporting Prosigna-guided treatment decisions," said Kelly Marcom, M.D., Veracyte’s medical director, Breast Cancer. "These findings have the potential to transform how clinicians treat a large population of patients with breast cancer, helping them to personalize their patient’s treatment choices using the genomic insights that the Prosigna test provides."

The ENZAMET trial is an international, prospective, randomized study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Dr. Christopher Sweeney of South Australian Immunogenomics Cancer Institute, Adelaide University, will present data on Saturday, May 30 during the Genitourinary Cancer session on Decipher Prostate’s ability to predict treatment benefit with the chemotherapy docetaxel in metastatic, hormone-sensitive prostate cancer. The independent analysis evaluated how the Decipher test can help identify which patients are most likely to benefit from treatment intensification with triplet therapy (docetaxel to standard of cancer hormonal therapy).

"Together, these studies provide practice-changing evidence supporting the use of Veracyte’s tests in guiding treatment decisions across cancer types," said Phillip Febbo, M.D., Veracyte’s chief scientific and medical officer. "In practice, this means clinicians can more confidently match treatment intensity to individual patient risk, helping ensure the right level of care while avoiding unnecessary treatment and its side effects, for both breast and prostate cancer patients."

Additional research to be presented at ASCO supports the company's mission to transform cancer care for patients all over the world.

Oral Presentations at ASCO 2026 Annual Meeting

• Title: First results from the OPTIMA phase III randomized non-inferiority trial of test-directed chemotherapy in patients with high clinical risk ER-positive HER2-negative early breast cancer
  • Presenter: Robert Stein, PhD, MBBChir, FRC, National Institute for Health Research University College London Hospitals Biomedical Research Centre
  • Session Title: Breast Cancer—Local/Regional/Adjuvant
  • Date/Time: Saturday, May 30, 2026, 1:15 PM CT
  • Location: Hall B1

• Title: Clinico-Transcriptomic Risk Stratification to Guide Abiraterone Treatment Intensification in High-Risk Prostate Cancer: A Combined Analysis of NRG/RTOG 9202, 9413, 9902, and 0521
  • Presenter: Krishnan R Patel, MD, MHS, Radiation Oncology Branch, National Cancer Institute, NIH
  • Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
  • Date/Time: Saturday, May 30, 2026, 3:00 PM CT
  • Location: Hall D1

• Title: Assessment of the ability of Decipher Prostate Genomic Classifier (DGC) >0.85 to identify patients who benefit from adding docetaxel (DOC) to androgen deprivation therapy (ADT) plus enzalutamide (ENZ): Level 1B evidence from the ENZAMET study
  • Presenter: Christopher Sweeney, MBBS, South Australian Immunogenomics Cancer Institute, Adelaide University
  • Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
  • Date/Time: Saturday, May 30, 2026, 3:12 PM CT
  • Location: Hall D1

• Title: Genomic classifier–driven NCCN risk reclassification to track distinct transcriptomic signatures in early prostate cancer
  • Presenter: Daniel Keizman, MD, Tel Aviv Sourasky Medical Center, Israel
  • Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
  • Date/Time: Sunday, May 31, 2026, 4:36 PM CT
  • Location: Hall D1

Additional Posters at ASCO

• Abstract #1660 | Poster bd #578: Titled: Practice patterns and outcomes by genomic risk in octogenarians with high-risk localized prostate cancer: a national real-world data analysis. Presenter: James Janopaul-Naylor – Saturday May 30, 2026 at 9:00 AM CDT, Hall A
• Abstract #4619 | Poster bd #98: Titled: Neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer: Final results and biomarker analyses of the SURE-01 trial. Presenter: Brigida A. Maiorano – Sunday, May 31, 2026 at 9:00 AM CDT, Hall A
• Abstract #5114 | Poster bd #209: Titled: Assessing the Clinical and Biological Associations Between Artera Multimodal Artificial Intelligence (MMAI) and Decipher Genomic Classifier (GC) in Localized Prostate Cancer (PCa). Presenter: Boon Hao Hong – Sunday, May 31, 2026 at 9:00 AM CDT, Hall A
• Abstract #4617 | Poster bd #96: Titled: Molecular characterization of residual disease post-neoadjuvant sacituzumab govitecan (SG), pembrolizumab, or their combination in patients with muscle-invasive bladder cancer (MIBC). Presenter: Andrea Necchi – Sunday, May 31, 2026 at 9:00 AM CDT, Hall A

For more information, stop by Veracyte’s booth #13069 at the ASCO Annual Meeting or visit the company’s website here.

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).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward‑looking statements, including, but not limited to, statements regarding the potential clinical utility, impact, and benefits of Veracyte’s Prosigna Breast Risk of Recurrence (ROR) test and Decipher Prostate test; the ability of these tests to guide treatment decisions in both early‑stage breast cancer and metastatic prostate cancer, including identifying patients who may benefit from or avoid certain therapies or treatment intensification; and the extent to which data from the OPTIMA and ENZAMET trials may be considered practice‑changing or influence clinical decision‑making. 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 and our subsequent Quarterly Reports on Form 10‑Q. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260521430337/en/

Investors:
Kelly Gura
investors@veracyte.com

Media:
Molly Cornbleet
media@veracyte.com
+1-858-742-1258

Source: Veracyte