Veracyte Announces Multiple Abstracts To Be Presented at ASCO, Demonstrating Power of Decipher GRID to Advance New Prostate and Bladder Cancer Research

On May 28, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that eight abstracts featuring data derived from testing with its Decipher Prostate and Decipher Bladder genomic classifiers will be presented at ASCO (Free ASCO Whitepaper), the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held May 30-June 3 in Chicago (Press release, Veracyte, MAY 28, 2025, View Source [SID1234653452]). Key findings shed new light on which patients with prostate or bladder cancer may be more likely to respond to specific therapies based on their tumors’ molecular make-up.

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"These new findings underscore the power of our whole-transcriptome-based Decipher GRID, or Genomic Resource for Intelligent Discovery, research tool to help advance understanding of urologic cancers at the molecular level," said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. "We are pleased to share this resource with the research community to help reveal new insights that could one day enable more-personalized care and outcomes for patients with prostate or bladder cancer."

The following Decipher Prostate GRID-focused abstract will be shared in a podium presentation at the McCormick Place convention center:

Title:

Transcriptome classification of PTEN inactivation to predict survival benefit from docetaxel at start of androgen deprivation therapy (ADT) for metastatic prostate cancer (PC): an ancillary study of the STAMPEDE trials.

Presenter:

Emily Grist, Ph.D., University College London Cancer Institute

Format:

Oral Abstract Presentation

Abstract #:

5003

Date/Time:

Tuesday, June 3; 9:45 a.m. – 12:45 p.m. CDT

Room:

Hall D

Researchers found that patients whose metastatic prostate cancer had a PTEN-inactive gene expression signature were more likely to benefit from the addition of the chemotherapy, docetaxel, to standard androgen deprivation therapy (ADT), compared to those with PTEN-active tumors. Specifically, the PTEN-inactive patients had a 43% reduction in risk of death (HR=0.57, 95% 0.42-0.76), unlike PTEN-active patients where no benefit from docetaxel was observed (HR=1.05, 95% CI 0.77-1.43), with a significant interaction observed between docetaxel and PTEN status (p=0.002). Additionally, docetaxel benefited patients with PTEN-inactive tumors regardless of whether they had high- or low-volume prostate cancer. Finally, patients with tumors that were both PTEN-inactive and had high Decipher Prostate test risk scores had the greatest benefit from the addition of chemotherapy.

The study involved 832 patients with metastatic prostate cancer who were followed for a median of 14 years as part of STAMPEDE—a large, multi-center, randomized Phase 3 clinical trial that aims to determine the best way to treat men with newly diagnosed advanced or metastatic prostate cancer. Previously presented data showed that patients with high Decipher Prostate Genomic Classifier risk scores were more likely to benefit from the addition of docetaxel to ADT, compared to those with low Decipher test scores.1

"It’s well known that adding docetaxel to ADT increases survival for some patients with metastatic prostate cancer. The challenge has been knowing which patients will benefit and which ones will not so the latter can avoid unnecessary toxicity," said Emily Grist, Ph.D., of the University College London Cancer Institute who will present the new findings at the ASCO (Free ASCO Whitepaper) meeting. "Our results help to further elucidate molecular features of advanced prostate cancer, which may help us better select treatments for our patients."

The following Decipher Bladder GRID-focused abstract will be shared in a podium presentation at the ASCO (Free ASCO Whitepaper) meeting:

Title:

First results of SURE-02: A Phase 2 study of Neoadjuvant Sacituzumab Govitecan (SG) plus Pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant Pembro, in patients with muscle-invasive bladder cancer (MIBC)

Presenter:

Andrea Necchi, M.D., IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy

Format:

Rapid Oral Abstract Presentation

Abstract #:

4518

Date/Time:

Saturday, May 31; 1:15 – 2:45 p.m. CDT

Room:

Arie Crown Theater

This study evaluated whether patients with muscle-invasive bladder cancer (MBIC) could potentially benefit from treatment with Sacituzumab Govitecan (SG) plus Pembrolizumab (Pembro), rather than standard-of-care chemotherapy, prior to radical cystectomy (RC). It also used the Decipher Bladder GRID research tool to identify patients who were more likely to achieve clinical complete response (cCR), based on the molecular underpinnings of their tumor.

"Interim results from SURE-02 trial revealed that neoadjuvant Sacituzumab Govitecan plus Pembrolizumab, followed by bladder sparing in complete responders and maintenance pembrolizumab was a safe and effective strategy in patients with MIBC," said Andrea Necchi, M.D., of IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University in Milan, Italy, who presented the findings. "Preliminary biomarker data developed by Veracyte as part of its Decipher Bladder test and GRID research tool, revealed associations between Luminal subtype and clinical complete response, or cCR, and immune signatures linked to the EFS gene that could ultimately help improve outcomes in molecularly-selected patients."

A more complete list of Decipher-focused abstracts to be presented at the ASCO (Free ASCO Whitepaper) meeting can be found on Veracyte’s website here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 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. More information about Decipher GRID can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

Supernus to Participate in the 2025 Jefferies Global Healthcare Conference

On May 28, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 2:00 p.m. ET in New York City (Press release, Supernus, MAY 28, 2025, View Source [SID1234653451]).

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Investors interested in arranging a meeting with company management during the conference should contact the Jefferies conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

Sana Biotechnology to Present at June 2025 Investor Conferences

On May 28, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentations at two investor conferences in June (Press release, Sana Biotechnology, MAY 28, 2025, View Source [SID1234653450]). The presentations will feature a business overview and update.

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Sana will present at the Jefferies Global Healthcare Conference at 2:35 p.m. ET on Wednesday, June 4, 2025.
Sana will present at the Goldman Sachs 46th Annual Global Healthcare Conference at 8:40 a.m. ET on Tuesday, June 10, 2025.
The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the conference.

Rigel to Present at the Jefferies Global Healthcare Conference

On May 28, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and CEO, will present a company overview at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 12:50 p.m. ET in New York, NY (Press release, Rigel, MAY 28, 2025, View Source [SID1234653449]).

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To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

ORIC® Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC

On May 28, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported potentially best-in-class preliminary efficacy and safety data from the ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, ORIC Pharmaceuticals, MAY 28, 2025, View Source [SID1234653448]).

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"These ORIC-944 combination data demonstrate substantial clinical activity with both AR inhibitors, apalutamide and darolutamide, through early measures of efficacy (PSA50 and PSA90 response rates) and a safety profile consisting almost entirely of mild to moderate GI related adverse events, making it highly suitable for potential long term dosing," said Pratik S. Multani, M.D., chief medical officer.

"The data generated to date continue to demonstrate the potential of ORIC-944 to be a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "The efficacy and safety data presented today compare favorably to other PRC2 inhibitor data presented earlier this year. We look forward to subsequent updates from the dose exploration and dose optimization portion of the Phase 1b trial over the next three quarters as we move towards initiating our first global registrational trial in 1H 2026."

ORIC-944 Phase 1b Trial Design
ORIC-944 is being evaluated in a Phase 1b dose exploration trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objectives of the trial are to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

ORIC-944 Phase 1b Dose Exploration Data
Data include 17 patients with mCRPC previously treated with a median of three lines of prior therapy, including abiraterone, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include androgen deprivation therapy or first-generation androgen receptor deprivation therapy. Patients were treated once daily with 400 mg, 600 mg, or 800 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA response data are as of May 9, 2025.

Preliminary activity analysis
59% of patients (10/17) achieved a PSA50 response and nearly all patients with a PSA50 response were confirmed one month later, for a confirmed PSA50 response rate of 47% (8/17), which does not include one additional PSA response pending confirmation. 24% of patients (4/17) achieved a PSA90 response, all of which were subsequently confirmed.

PSA responses were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide. The majority of patients are still ongoing with multiple patients approaching one year or more on therapy. Further dose exploration is ongoing.

Preliminary safety analysis
ORIC-944 in combination with apalutamide or with darolutamide has been generally well tolerated to date, with a vast majority of adverse events (AEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of April 22, 2025, diarrhea was the most common treatment-related AE, occurring in 53% of patients (9/17) across all dose levels with only one patient experiencing a Grade 3 event. There were no Grade 4 or Grade 5 treatment-related AEs attributed to ORIC-944 with apalutamide or with darolutamide.

Next Steps
Following completion of the Phase 1b dose exploration portion of the trial expected in mid-2025, the company plans to evaluate two candidate RP2Ds for each combination in the dose optimization portion of the trial in 2H 2025. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC that the company expects to initiate in 1H 2026.

Corporate Update
The company announced a concurrent $125 million private placement financing that it expects will extend cash runway into the second half of 2027 and through the anticipated primary endpoint readout from the first ORIC-944 Phase 3 registrational trial in mCRPC. The financing is expected to close on May 29, 2025, subject to customary closing conditions.

Conference Call and Webcast Details
ORIC will host a conference call and webcast today at 4:30 p.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

About ORIC-944
ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA (apalutamide) and in combination with NUBEQA (darolutamide) for prostate cancer (NCT05413421).