Agendia Publishes MammaPrint® Study on Extended Endocrine Therapy in Journal of Clinical Oncology

Agendia, Inc., a leader in precision oncology, recently announced the publication of a significant study in the Journal of Clinical Oncology. This study, part of the NSABP B-42 trial, evaluates the effectiveness of the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) for patients with early-stage breast cancer.

The research, entitled "Utility of the 70-gene MammaPrint Assay for Prediction of Benefit from Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial," revealed that the MammaPrint assay is effective in identifying early-stage hormone receptor-positive (HR+) breast cancer patients who could benefit from extended endocrine therapy. Specifically, patients classified by MammaPrint as Low Risk (scores ranging from 0.000 to +0.355) showed improved outcomes when treated with EET.

The NSABP B-42 trial (NCT00382070) is a phase III, double-blind, placebo-controlled study involving 3,966 postmenopausal women with HR+ early-stage breast cancer. These patients had completed five years of endocrine therapy with either an aromatase inhibitor (AI) or at least three years of tamoxifen followed by AI. Participants were then randomly assigned to receive either an additional five years of letrozole or a placebo. Results indicated that although EET modestly reduced recurrence risk, further stratification was necessary to identify those who would derive significant benefit from EET.

In a subset analysis of 1,866 patients, representative of the overall trial population, MammaPrint was used to classify tumors into High Risk (706 patients) and Low Risk (1,160 patients) categories. The Low Risk group was further divided into UltraLow Risk (+0.356 to +1.000) (252 patients) and Low (non-UltraLow) Risk (908 patients). The data indicated that only the Low (non-UltraLow) Risk group showed significant benefits from EET, with a 9.5% improvement in 10-year disease-free survival (DFS) and a 7.9% improvement in the breast cancer-free interval (BCFI). In contrast, neither UltraLow nor High Risk tumors exhibited a statistically significant benefit from EET. These results position MammaPrint Low (non-UltraLow) Risk as a critical predictive biomarker for determining EET efficacy.

Dr. William Audeh, Chief Medical Officer at Agendia, noted that the study confirms MammaPrint's utility in identifying HR+ early-stage breast cancer patients who would benefit from EET. He emphasized that while clinical factors can predict late recurrence risk, they do not indicate whether such recurrences are preventable. The findings demonstrate MammaPrint's value in predicting which patients are at risk of preventable late recurrence through EET. The study adds substantial evidence supporting MammaPrint's role in early breast cancer management, aiming to enhance the standard of care.

Agendia is recognized for its innovative solutions in precision oncology, focusing particularly on early-stage breast cancer. The company offers genomic assays such as MammaPrint and BluePrint, which aid clinicians in crafting personalized treatment plans. Agendia, founded in 2003 in Amsterdam and headquartered in Irvine, California, operates a state-of-the-art laboratory facility. The organization remains dedicated to advancing genomic research to improve breast cancer management, with initiatives like the FLEX Study, the world’s largest whole transcriptome real-world evidence-based breast cancer database.

The MammaPrint assay evaluates 70 key genes to predict a tumor's risk of metastasis, making it the only FDA-cleared test of its kind. By providing insights at diagnosis, MammaPrint assists in planning the most effective treatment strategies, including the timing and benefit of chemotherapy and endocrine therapy. BluePrint, another genomic assay from Agendia, analyzes 80 genes to identify the molecular subtype of a tumor, aiding in the personalization of treatment plans. BluePrint distinguishes between Luminal-type, HER2-type, and Basal-type tumors, and can identify aggressive Basal tumors that might otherwise be misclassified, ensuring that patients receive the most appropriate treatment from the outset.

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