Agendia Announces Publication in JNCI Cancer Spectrum Demonstrating that MammaPrint ® Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer Using Real-World Evidence from the FLEX Study

Agendia, Inc., a leader in innovative genomic testing for breast cancer, today announced the publication of new findings in JNCI Cancer Spectrum validating the predictive utility of the MammaPrint 70-gene assay for chemotherapy benefit in patients with hormone receptor-positive, HER2-negative (HR+HER2-) early-stage breast cancer. The peer-reviewed article, titled "MammaPrint Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer: FLEX Registry Real-World Data," highlights how the MammaPrint Index predicts benefit from chemotherapy using a real-world, prospective, observational dataset.

The findings are based on data from the ongoing FLEX Study (NCT03053193), a real-world data (RWD) study designed to collect whole transcriptome genomic data annotated with clinical data and outcomes from patients undergoing standard of care MammaPrint testing. This analysis included a propensity-score matched cohort of 1,002 patients with HR+HER2- breast cancer who received either chemotherapy with endocrine therapy or endocrine therapy only, with 5-year median follow-up. The results demonstrate that the MammaPrint Index is a strong continuous predictor of distant recurrence-free interval (DRFI) and chemotherapy benefit.

“This propensity-score matched population offers statistically robust evidence supporting the benefit of chemotherapy for patients with MammaPrint High Risk cancers. At the same time, it supports foundational results from MINDACT (NCT00433589) that showed no significant benefit of chemotherapy for patients with MammaPrint Low Risk breast cancer,” said Adam Brufsky, MD, PhD, Professor of Medicine at UPMC and first author of the study. “These findings strengthen the evidence that MammaPrint is a chemopredictive comprehensive genomic test for guiding treatment decisions in early-stage breast cancer.”

Key Findings:

• The study showed that the MammaPrint Index was significantly predictive of 5-year DRFI for both endocrine therapy only (R²=0.99, p<0.001) and endocrine therapy + chemotherapy (R²=0.90, p<0.001).
• Chemotherapy provided the greatest absolute benefit of up to 14.2% (average: 10.9%) to patients with MammaPrint High Risk 2 (H2) breast cancer, with an average 5.5% benefit for High Risk 1 (H1), and minimal benefit in Low or UltraLow Risk categories.
• A multivariate Cox model confirmed a significant interaction between the MammaPrint Index and chemotherapy benefit (HR=0.15, p=0.047), independent of age, tumor stage, nodal status, or grade.

“This study marks a milestone in the large body of data supporting the predictive value of MammaPrint in breast cancer, and underscores Agendia’s commitment to providing robust, clinically actionable genomic insights that personalize care and improve outcomes for individuals diagnosed with breast cancer,” said William Audeh, MD, MS, Chief Medical Officer at Agendia. “It also highlights the growing impact of the FLEX Study, which has now enrolled more than 20,000 breast cancer patients and continues to make meaningful contributions to the field of breast cancer research.” The publication is available online in JNCI Cancer Spectrum.

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.

Agendia was founded in 2003 with headquarters in Amsterdam and a state-of-the-art laboratory facility located in Irvine, CA. 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.

About MammaPrint^®

MammaPrint is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint listens to the signals from 70 key genes in a woman’s tumor to stratify the risk of recurrence within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans.

About BluePrint^®

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 to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint measures the activity of 80 key genes that are involved in a tumor’s growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman’s tumor, BluePrint can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

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