New Neoadjuvant Trial Confirms the Predictive Utility of MammaPrint® + BluePrint®

Study shows that patients with genomically high-risk breast cancer, as defined by MammaPrint with or without BluePrint, respond better to neoadjuvant chemotherapy and have a higher likelihood of nodal downstaging

IRVINE, Calif. & AMSTERDAM, Sept. 28, 2023 /PRNewswire/ -- Agendia^®, Inc., a global leader in innovative genomic technology and diagnostic tests, announced today the publication of the Multi-Institutional Neoadjuvant Therapy MammaPrint Project I (MINT) trial, a prospective study designed to evaluate the utility of molecular profiling alongside traditional pathologic and clinical prognostic factors in predicting the response to neoadjuvant chemotherapy (NCT) in patients with locally advanced breast cancer (LABC).

The MINT trial enrolled 387 patients between 2011 and 2016 with invasive breast cancer (T2-T4), with a subanalysis published today that included 146 patients with stage II-III, lymph node positive who received NCT. This is the first neoadjuvant study to show that nodal downstaging in response to neoadjuvant therapy can be predicted by MammaPrint + BluePrint, Agendia's advanced genomic assays.

Together, MammaPrint + BluePrint identify molecular subtypes that provide more information which will help/aid in selecting the optimal treatment plan for patient with early stage breast cancer than clinical factors alone.

The MINT study found that patients with genomically high-risk tumors, as identified by MammaPrint with or without BluePrint, had higher proportions of nodal downstaging than in the overall lymph node-positive cohort. Data from the trial suggests that treating patients with clinically HR+HER2–, but MammaPrint Low Risk and BluePrint Luminal subtype, genomically Luminal A tumors, with chemotherapy for the purpose of nodal downstaging is likely to yield suboptimal results.

Overall, 45.2% of patients had complete nodal downstaging with clearance of all cancer within lymph nodes, with 60.6% of those having also achieved a pCR in the breast. Results from the study suggest that MammaPrint + BluePrint, by identifying tumors with a high likelihood of nodal downstaging in response to neoadjuvant chemotherapy, may help identify good candidates for less invasive axillary procedures such as TAD (targeted axillary dissection), which may reduce the risk of lymphedema and improve patient outcomes.  

"The publication of these findings marks a critical advance in the ongoing effort to enhance neoadjuvant treatment strategies for Stage II and III patients with the application of gene expression profiling," said Dr. William Audeh, MD, MS, Chief Medical Officer of Agendia. "Our subanalysis of treatment response in the lymph  node positive cohort underscores the value of gene expression profiling in breast cancer treatment planning and reinforce the clinical utility of MammaPrint and BluePrint in the neoadjuvant setting, leading to more personalized, effective, and less invasive treatment decisions for women with breast cancer."

The MINT trial represents a collaboration of leading institutions and researchers dedicated to advancing breast cancer treatment. It reaffirms the commitment of the scientific and medical communities to improve patient care and outcomes through cutting-edge research. The full publication appears in the Annals of Surgical Oncology. For more information about Agendia, visit www.agendia.com and follow Agendia on Facebook, Twitter,  and LinkedIn.

About Agendia
Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint^® + BluePrint^®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment.

Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.

SOURCE Agendia