Four additional poster presentations from the ongoing real-world FLEX Study highlight the value of real-world data in personalizing chemotherapy decisions and improving outcomes in early-stage breast cancer
Agendia®, Inc., a leader in precision oncology for breast cancer, today announced that it will present new data demonstrating the utility of the MammaPrint® 70-gene assay (MP) and BluePrint® 80-gene assay (BP) genomic profiling in guiding the use of anthracycline chemotherapy in patients with hormone receptor positive, HER2-negative (HR+HER2–) early-breast cancer (EBC) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The company will also present four additional posters at SABCS, which takes place December 9-12 in San Antonio, Texas. The complete list of poster presentations can be found here.
The latest 3-year analysis from the prospective FLEX Study, in an update to data presented at ASCO 2024, confirms that patients with MP High 2 (H2), Luminal B, HR+HER2- EBC experience substantially improved invasive disease-free survival when treated with anthracycline-based chemotherapy (AC-T) compared to a regimen without anthracycline (TC). While outcomes for High 1 (H1) patients were similar between patients matched for clinical features, H2 patients saw a striking absolute invasive disease-free survival (IDFS) benefit of 10.7% with AC-T, achieving 100% 3-year IDFS. These results provide the strongest real-world evidence to date that MP can help identify the subset of HR+HER2- patients most likely to benefit from anthracycline-based therapy. Together, these findings underscore the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.
“With the addition of propensity score matching, these results demonstrate how the genomic information provided by MammaPrint and BluePrint can meaningfully support adjuvant treatment decisions and therapy selection for patients with HR+HER2- early breast cancer,” said William Audeh, MD, MS, Chief Medical Officer at Agendia. “By distinguishing High 2 patients – who derive substantial benefit from the addition of anthracycline to their chemotherapy regimen – from those with High 1 disease, who do not, we can better tailor therapy to each patient’s underlying tumor biology. These data further establish the value of real-world evidence and reinforces the power of precision genomics to guide more effective, individualized care and improve outcomes for patients with breast cancer.”
Poster #PS2-07-03 | Dec. 10, 5:00 p.m. - 6:30 p.m. | Presenter: Joyce O'Shaughnessy
Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC
In this real-world cohort of 1,261 HR+/HER2– breast cancer patients with MP High Risk and BP Luminal B tumors from the FLEX Study, outcomes were evaluated in propensity-matched treatment groups with a median follow-up of 3.2 years. Patients with MP High Risk 2 tumors demonstrated a statistically significant improvement of 10.7% in invasive disease-free survival when treated with anthracycline-based therapy compared to TC-only regimens, while those with High 1 tumors saw no difference. These results provide real-world evidence that MP can identify the HR+/HER2- patients most likely to benefit from anthracycline-based therapy, underscoring the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.
Agendia will present four additional abstracts that collectively highlight the broad clinical impact of MP and BP in optimizing treatment decisions and improving outcomes for patients with HR+/HER2– EBC, including a poster demonstrating that MP is more prognostic than histologic grade, as described below.
Poster #PS5-04-19 | Dec. 12, 12:30 p.m. - 2:00 p.m. | Presenter: Erin Cobain
70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC
In this real-world analysis of 1,407 HR+HER2– EBC patients enrolled in the FLEX Study, patients with MP High 2 tumors treated with chemotherapy had significantly worse five-year distant relapse-free survival compared to High 1 tumors (86.4% vs 93.1%; p < 0.001), even after adjusting for clinicopathologic factors such as grade. Notably, grade lost independent prognostic value when corrected for MP score – highlighting the limitations of relying on histology alone and establishing MP as a superior prognostic biomarker.
“The data being presented at SABCS continue to build on the growing body of evidence supporting the expanded clinical utility of MammaPrint and BluePrint,” said Mark Straley, Chief Executive Officer. “Each study adds a new dimension to how our tests inform multiple treatment decisions across the care journey for patients with early-stage breast cancer – helping more women receive the right care based on the unique biology of their tumor.”
The complete list of presentations can be found here.
About Agendia
Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company’s genomic assays, MammaPrint® and BluePrint®, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.
About MammaPrint
MammaPrint is the only FDA-cleared gene expression profiling test that assesses a woman’s risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories — UltraLow, Low, High 1, and High 2 — to help guide treatment planning, including chemotherapy benefits and de-escalation decisions.
About BluePrint
BluePrint is a molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.
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