FLEX data underscores MammaPrint^® utility in accurately predicting 3-year outcome in patients with High Risk early-stage breast cancer when treated with neo/adjuvant chemotherapy

Agendia^®, Inc. today announced it will present new data on the 3-year outcome of patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer when treated with two different chemotherapy regimens at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on May 31^st, 2024.

The data will be presented in an oral discussion by Joyce O’Shaughnessy MD, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the Sarah Cannon Research Institute in Dallas, TX, Primary Investigator of the FLEX Study, titled Association of MammaPrint index and 3-year outcome of patients with HR+HER2- early-stage breast cancer treated with chemotherapy with or without anthracycline [O'Shaughnessy, J., et al.]. The FLEX study investigates the 3-year outcome of patients with HR+HER2-, genomically High Risk Luminal B-Type early breast cancer, who have undergone treatment consisting of chemotherapy with taxane and cyclophosphamide (TC) or chemotherapy with anthracycline + TC (AC-T). All patients are enrolled in the prospective, non-randomized, observational FLEX Study (NCT03053193). This study utilized both MammaPrint and BluePrint® to determine tumor subtype.

Results showed that patients with MammaPrint H1 Luminal B-Type tumors demonstrated similar 3-year outcomes when treated with either TC (97.1%) or AC-T (95.3%), suggesting that patients who are classified as H1 may be able to avoid the toxicity of an anthracycline. However, patients with MammaPrint H2 Luminal B-Type tumors demonstrated a significantly higher relapse-free survival when treated with AC-T (97.7%) than with TC alone (86.4%). These findings indicate that MammaPrint H2 tumors benefit from the addition of an anthracycline to their adjuvant chemotherapy regimen.

"The ability to tailor treatment regimens to a patient’s tumor biology is crucial to optimize outcomes and quality of life. MammaPrint's utility in guiding treatment planning is highlighted by these new data evaluating chemotherapy selection," said Dr. O'Shaughnessy. "The FLEX Study and sub-studies, such as this one, enable increased precision in identifying patients that are more responsive to specific systemic therapy regimens, and continue to aid selection of treatments for patients with HR+/HER2-negative early-stage breast cancer."

“These new findings demonstrate the strength of the FLEX research platform in evaluating the different aspects of breast cancer during its diagnosis and treatment stages, allowing for more precise and individualized treatment recommendations,” said William Audeh, MD, Chief Medical Officer at Agendia. “This study offers a preliminary signal towards groundbreaking insight into MammaPrint High Risk tumors and how they best respond to chemotherapy regimens, underscoring the clinical utility of MammaPrint in the selection of treatment. We remain committed to advancing breast cancer research to help deliver the best standard of practice to women undergoing breast cancer care.”

Additional data supporting MammaPrint utility in treatment selection will be presented by investigators from the ISPY2 trial in a poster titled Hormone Receptor Positive HER2-negative/MammaPrint High-2 Breast Cancer Closely Resembles Triple Negative Breast Cancer: Results from Gene Expression Data from the ISPY2 Trial [Rios-Hoyo, A., et al.]. By using data from the ISPY-2 trial, this poster demonstrates that MammaPrint H2 tumors have molecular and clinical similarities to triple negative breast cancer tumors, underscoring critical insight into how treatment plans can be optimized to achieve the best result for the patient.

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

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.

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 her risk 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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