New Data Presented at ESMO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer
Veracyte (NASDAQ: VCYT) presented new data at ESMO 2024 showing that its Decipher Prostate Genomic Classifier predicts chemotherapy benefit in patients with metastatic prostate cancer. The findings, from an ancillary study of the phase 3 STAMPEDE trial, support Veracyte's plan to expand the Decipher Prostate test to metastatic disease.
Key findings include:
- Higher Decipher scores were associated with increased risk of death
- Patients with higher scores showed a 36% reduction in death risk with docetaxel addition
- The test predicted benefit regardless of cancer volume
Veracyte plans to offer the test for metastatic prostate cancer in early 2025, pending Medicare reimbursement. This expansion demonstrates the power of Veracyte's Diagnostics Platform in delivering high-performing cancer tests and generating evidence for reimbursement and adoption.
Veracyte (NASDAQ: VCYT) ha presentato nuovi dati all'ESMO 2024 che mostrano come il suo Decipher Prostate Genomic Classifier preveda i benefici della chemioterapia nei pazienti con cancro alla prostata metastatico. I risultati, provenienti da uno studio accessorio della fase 3 della sperimentazione STAMPEDE, supportano il piano di Veracyte di ampliare il test Decipher Prostate per la malattia metastatica.
I risultati chiave includono:
- Punteggi Decipher più elevati erano associati a un aumento del rischio di morte
- I pazienti con punteggi più alti hanno mostrato una riduzione del 36% nel rischio di morte con l'aggiunta di docetaxel
- Il test ha previsto il beneficio indipendentemente dal volume tumorale
Veracyte prevede di offrire il test per il cancro alla prostata metastatico all'inizio del 2025, subordinato al rimborso da parte di Medicare. Questa espansione dimostra la potenza della Piattaforma Diagnostica di Veracyte nel fornire test oncologici ad alte prestazioni e generare prove per il rimborso e l'adozione.
Veracyte (NASDAQ: VCYT) presentó nuevos datos en ESMO 2024 que muestran que su Decipher Prostate Genomic Classifier predice los beneficios de la quimioterapia en pacientes con cáncer de próstata metastásico. Los hallazgos, de un estudio auxiliar del ensayo de fase 3 STAMPEDE, respaldan el plan de Veracyte de expandir la prueba Decipher Prostate a la enfermedad metastásica.
Los hallazgos clave incluyen:
- Se asociaron puntuaciones Decipher más altas con un mayor riesgo de muerte
- Los pacientes con puntuaciones más altas mostraron una reducción del 36% en el riesgo de muerte con la adición de docetaxel
- La prueba predijo el beneficio independientemente del volumen del cáncer
Veracyte planea ofrecer la prueba para el cáncer de próstata metastásico a principios de 2025, a la espera del reembolso de Medicare. Esta expansión demuestra la capacidad de la Plataforma de Diagnósticos de Veracyte para proporcionar pruebas de cáncer de alto rendimiento y generar evidencias para el reembolso y la adopción.
Veracyte (NASDAQ: VCYT)는 ESMO 2024에서 발표한 새로운 데이터에서 자사의 Decipher Prostate Genomic Classifier가 전이성 전립선암 환자에서 화학요법의 이점을 예측한다고 밝혔습니다. 이 발견은 3상 STAMPEDE 시험의 부가 연구 결과이며, Veracyte가 전이성 질환에 대한 Decipher Prostate 테스트를 확장할 계획을 지원합니다.
주요 발견 사항은 다음과 같습니다:
- 높은 Decipher 점수가 사망 위험 증가와 관련이 있었습니다.
- 더 높은 점수를 가진 환자는 도세탁셀 추가로 사망 위험이 36% 감소했습니다.
- 이 검사는 암의 양과 관계없이 이익을 예측했습니다.
Veracyte는 2025년 초에 전이성 전립선암을 위한 테스트를 제공할 계획이며, 이는 Medicare의 환급을 조건으로 합니다. 이 확장은 Veracyte의 진단 플랫폼이 높은 성능의 암 테스트를 제공하고 환급 및 채택을 위한 증거를 생성하는 능력을 보여줍니다.
Veracyte (NASDAQ: VCYT) a présenté de nouvelles données lors de l'ESMO 2024, montrant que son Decipher Prostate Genomic Classifier prédit les bénéfices de la chimiothérapie chez les patients atteints de cancer de la prostate métastatique. Les résultats, provenant d'une étude accessoire de l'essai de phase 3 STAMPEDE, soutiennent le plan de Veracyte d'étendre le test Decipher Prostate aux maladies métastatiques.
Les résultats clés incluent :
- Des scores Decipher plus élevés étaient associés à un risque accru de mortalité
- Les patients ayant des scores plus élevés ont montré une réduction de 36 % du risque de mortalité avec l'ajout de docétaxel
- Le test a prédit un bénéfice indépendamment du volume tumorale
Veracyte prévoit de proposer le test pour le cancer de la prostate métastatique début 2025, sous réserve du remboursement par Medicare. Cette extension démontre la puissance de la plateforme diagnostique de Veracyte pour fournir des tests de cancer performants et générer des preuves pour le remboursement et l'adoption.
Veracyte (NASDAQ: VCYT) hat auf der ESMO 2024 neue Daten präsentiert, die zeigen, dass ihr Decipher Prostate Genomic Classifier den Nutzen einer Chemotherapie bei Patienten mit metastasiertem Prostatakrebs vorhersagt. Die Ergebnisse stammen aus einer Begleitstudie der Phase-3-Studie STAMPEDE und unterstützen Veracytes Plan, den Decipher Prostate-Test auf metastatische Erkrankungen auszuweiten.
Wichtige Ergebnisse umfassen:
- Höhere Decipher-Werte waren mit einem erhöhten Sterblichkeitsrisiko assoziiert.
- Patienten mit höheren Werten zeigten ein um 36% reduziertes Sterberisiko bei zusätzlicher Gabe von Docetaxel.
- Der Test sagte den Nutzen unabhängig vom Tumorvolumen voraus.
Veracyte plant, den Test für metastasierenden Prostatakrebs Anfang 2025 anzubieten, vorbehaltlich der Erstattung durch Medicare. Diese Expansion zeigt die Leistungsfähigkeit von Veracytes Diagnostik-Plattform bei der Bereitstellung hochwirksamer Krebserkennungstests und der Generierung von Beweisen für Erstattung und Akzeptanz.
- New data shows Decipher Prostate test predicts chemotherapy benefit in metastatic prostate cancer
- Findings support expansion of Decipher Prostate test to metastatic disease
- 36% reduction in risk of death for patients with higher Decipher scores receiving docetaxel
- Test predicts benefit regardless of cancer volume, potentially expanding docetaxel use
- Planned offering for metastatic prostate cancer in early 2025
- Recent MolDX local coverage determination provides potential pathway for Medicare reimbursement
- None.
Insights
The new data from the STAMPEDE trial significantly bolsters the clinical utility of Veracyte's Decipher Prostate test. The study demonstrates that the test can predict chemotherapy benefit in metastatic prostate cancer patients, a important advancement in personalized treatment. With a 36% reduction in death risk for patients with higher Decipher scores receiving docetaxel, this test could revolutionize treatment decisions.
Importantly, the test's predictive power was independent of tumor volume, challenging current clinical practices. This could lead to more precise treatment strategies, potentially improving outcomes for patients previously considered unsuitable for chemotherapy. The
This study presents a significant leap in metastatic prostate cancer management. The Decipher Prostate test's ability to stratify patients who will benefit from docetaxel addresses a critical clinical need. Currently, we often rely on tumor volume to guide chemotherapy decisions, which can be imprecise. This genomic approach could refine our treatment paradigm, potentially sparing some patients from unnecessary chemotherapy while ensuring others receive life-extending treatment.
The test's prognostic value across both ADT and ADT+docetaxel groups further validates its clinical utility. As we face a projected doubling of prostate cancer deaths over the next two decades, tools like this become invaluable in optimizing patient care and resource allocation.
Veracyte's announcement could significantly impact its market position and financial outlook. The expansion of the Decipher Prostate test to metastatic patients represents a substantial market opportunity, given that metastatic cases often lead to the highest mortality rates. With
The anticipated Medicare reimbursement in early 2025 is a important catalyst for adoption and revenue growth. The test's Level 1B evidence status in NCCN Guidelines for localized prostate cancer, coupled with these new data, positions Veracyte strongly for reimbursement approval. This could drive both top-line growth and margin expansion, potentially boosting Veracyte's stock performance in the medium to long term.
Findings are from ancillary study of phase 3 STAMPEDE trial
Data support company’s plan to expand Decipher Prostate test to patients with metastatic disease
Prostate cancer accounts for a fifth (approximately 375,000) of all male cancer-related deaths globally and the number is expected to double over the next two decades.1 In
“For patients with metastatic prostate cancer, adding the chemotherapy docetaxel to standard-of-care androgen deprivation therapy (ADT) can increase survival. However, patient response varies and today physicians have limited tools for identifying who will likely benefit from the drug and who won’t,” said Gerhardt Attard, M.D., Ph.D., Professor and John Black Charitable Foundation Endowed Chair in Urological Cancer Research at University College London and STAMPEDE trial co-investigator. “Our findings are important because they show that the Decipher Prostate test can help clinicians better distinguish patients with metastatic prostate cancer who receive the greatest benefit from docetaxel from those who don’t and may therefore avoid unnecessary toxicity.”
In the new study, researchers analyzed data for 1,523 patients with advanced or metastatic prostate cancer who were followed in the STAMPEDE trial for a median of 14 years. They found that higher Decipher Prostate test scores were associated with an increased risk of death in both groups. Additionally, among the 832 patients with metastatic disease, only those with higher Decipher Prostate scores received a significant survival benefit from the addition of docetaxel to ADT. These patients had a
Notably, docetaxel was beneficial in patients with higher Decipher Prostate scores regardless of whether they had high- or low-volume prostate cancer. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.
“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer is already proven in dozens of peer-reviewed publications and is the only molecular test to achieve ‘Level 1B’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer. We believe our test can have a tremendous positive impact on care for these patients.”
Veracyte expects to begin offering the Decipher Prostate test to patients with metastatic prostate cancer in early 2025, after its anticipated reimbursement by Medicare. MolDX, a program that establishes Medicare coverage for advanced molecular diagnostic tests, recently issued a local coverage determination for molecular testing in patients with metastatic prostate cancer, providing what Veracyte believes is a pathway to coverage for its test.
“We are excited about the new Decipher Prostate data presented at ESMO and the opportunity to advance cancer care for even more patients,” said Marc Stapley, Veracyte’s chief executive officer. “These important advances clearly demonstrate the power of our Veracyte Diagnostics Platform, which delivers high-performing cancer tests and a powerful evidence-generation engine. Ultimately, this novel approach helps drive widespread test reimbursement and adoption, along with new insights to support our pipeline. This includes expanding the use of Decipher Prostate now to patients across the prostate cancer continuum, from those who are low risk and can benefit from active surveillance, to those who are metastatic and can benefit from chemotherapy.”
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 with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in more than 80 published studies involving more than 100,000 patients. More information about the Decipher Prostate test can be found here.
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 Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to our statements related to the potential for the Decipher Prostate test to provide better prognostic information for patients with prostate cancer and guide treatment; the potential pathway to test reimbursement and adoption; and that the Decipher Prostate test can have a positive impact on patient care and advance cancer care. 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, and include, but are not limited to the potential impact the Decipher Prostate test can have on scientific advancements in prostate cancer and, in turn, patients. 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 29, 2024 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.
Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the
1 James, N. D. et al. The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet 403, 1683–1722 (2024).
2 American Cancer Society. Cancer Facts & Figures 2024.
* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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Source: Veracyte, Inc.
FAQ
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