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Landmark OPTIMA Trial Delivers Practice-Changing Evidence that Veracyte’s Prosigna Test Identifies Patients with High-Risk Breast Cancer Who Can Safely Avoid Chemotherapy
Landmark OPTIMA Trial Delivers Practice-Changing Evidence that Veracyte’s Prosigna Test Identifies Patients with High-Risk Breast Cancer Who Can Safely Avoid
About this update from Veracyte, Inc.
Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced today results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) trial, led by University College London (UCL). The results, which will be presented at the ASCO Annual Meeting, conclude that the Prosigna® Breast Risk of Recurrence (ROR) test safely guides adjuvant chemotherapy decisions in patients with early-stage, ER-positive HER2-negative breast cancer. "Behind every breast cancer treatment decision is a patient asking, 'Do I really need chemotherapy?'" said Prof. Robert Stein, Lead Investigator, University College London. "OPTIMA answers this question with robust evidence. These study results can be practice-changing – we can now use the Prosigna test to predict which high-risk patients can safely avoid chemotherapy and its lasting side effects without compromising outcomes. That is a profound shift for patients and the clinicians who care for them." The Phase III prospective, randomized controlled trial compared standard of care – chemotherapy followed by hormone therapy – to treatment guided by Prosigna test results: patients with high ROR scores (>60) received chemotherapy followed by hormone therapy while those with low ROR scores (≤60) received hormone therapy alone. Key Trial Findings The OPTIMA trial results demonstrate: Chemotherapy can be safely avoided for many patients: The Prosigna test identified that 68% of patients with clinically high-risk node-positive breast cancer, who previously would have received chemotherapy, could safely forgo it entirely. These patients achieved 5-year cancer-free survival rates of 93.7% -- statistically noninferior to the 94.9% achieved with chemotherapy -- demonstrating that omitting treatment for these patients does not compromise outcomes or increase recurrence risk. Robust results across broadest range of high-risk subgroups: Non-inferiority was confirmed in previously under-studied populations where treatment guidance has been most uncertain, demonstrating that tumor biology, vs clinical factors alone, can guide chemotherapy decisions for: Premenopausal women treated with ovarian function suppression (HR 1.04; 90% CI 0.60–1.80) Patients with extensive nodal involvement (4–9 positive nodes, or pN2 disease) (HR 1.19; 95% CI 0.62–2.29) Highest level of prospective...