Agendia, Inc. has announced that new data from its ongoing FLEX Study will be presented at the upcoming ESMO Breast Cancer 2025 congress, taking place May 14-17 in Munich, Germany and virtually. The research highlights the clinical utility of BluePrint, the company's 80-gene molecular subtyping assay, in guiding treatment decisions for early-stage breast cancer patients.
The FLEX Study (NCT03053193) is a prospective real-world evidence, observational breast cancer study designed to correlate whole transcriptome gene expression with clinical outcomes in early-stage breast cancer. This particular analysis examined BluePrint's impact on pathological complete response (pCR) rates and chemotherapy decision-making in patients with hormone receptor-positive (HR+), HER2-negative tumors classified as High Risk by MammaPrint.
BluePrint Identifies Chemotherapy-Responsive Tumors
The research found that BluePrint effectively stratified MammaPrint High Risk, HR+ HER2- tumors into Basal or Luminal B subtypes, providing a more nuanced understanding of tumor biology and potential treatment response. Patients with Basal-type tumors were significantly more likely to achieve a pathological complete response following neoadjuvant chemotherapy compared to those with Luminal B tumors.
"These results reinforce the value of BluePrint in helping physicians personalize treatment plans for early-stage breast cancer," said Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center. "By identifying Basal-type tumors that are more likely to respond to chemotherapy, BluePrint can guide decisions about treatment intensity and timing that align with each patient's individual tumor biology."
Impact on Treatment Decision-Making
The analysis examined two cohorts from the FLEX Study: one consisting of patients who underwent genomic analysis on pre-operative core needle biopsy and received neoadjuvant chemotherapy with available pCR data, and another cohort with documented physician chemotherapy recommendations.
The findings revealed that Basal-type tumors were:
- More frequently recommended for chemotherapy overall
- More often treated with neoadjuvant chemotherapy specifically
- Prescribed more intensive chemotherapy regimens compared to Luminal B tumors
These results suggest that BluePrint provides actionable molecular insights that physicians are using to inform real-world treatment decisions, even among patients already eligible for chemotherapy based on MammaPrint High Risk status.
Clinical Significance in Breast Cancer Management
Breast cancer is a heterogeneous disease with varying biological characteristics that influence treatment response and patient outcomes. Traditional pathology methods may not fully capture the underlying molecular drivers of tumor growth and treatment sensitivity.
BluePrint measures the activity of 80 key genes involved in tumor growth to classify tumors as Luminal-type, HER2-type, or Basal-type, each warranting distinct treatment approaches. As the only molecular subtyping test available in the U.S., BluePrint can identify often misclassified, yet highly aggressive Basal tumors, enabling more appropriate treatment selection from the start.
The ability to distinguish between Basal and Luminal B subtypes within the HR+ HER2- High Risk population represents an important advancement in precision oncology, potentially sparing some patients from unnecessary chemotherapy while ensuring others receive appropriately intensive regimens.
Study Details and Presentation
The poster presentation, titled "The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P]," (A.M. Brufsky, et al.), will be presented on Thursday, May 15, at 12:00 PM CEST at the ICM International Congress Center of the Munich Messe, Hall B0.
About Agendia and BluePrint
Agendia is a leading provider of innovative solutions in precision oncology, focusing on early-stage breast cancer. Founded in 2003 and headquartered in Amsterdam with a laboratory facility in Irvine, California, the company offers genomic assays that inform personalized treatment decisions.
BluePrint is a gene expression profiling test that reveals the driving forces behind a tumor's growth at the earliest stage possible in a woman's breast cancer care journey. The test measures the activity of 80 key genes to classify tumors into subtypes that warrant distinct treatment approaches, helping optimize and personalize treatment planning.
The FLEX Study represents the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database, aiming to revolutionize precision in breast cancer management through ongoing research and genomic insights.
