Agendia to Present 3-Year Chemotherapy Outcome Data for Early-Stage Breast Cancer at 2024 ASCO

Agendia, Inc. is set to unveil new findings on the 3-year outcomes for patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer treated with different chemotherapy regimens at the upcoming 2024 Annual American Society of Clinical Oncology (ASCO) Meeting in Chicago. The presentation will be delivered by Dr. Joyce O'Shaughnessy, Director of Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and the Sarah Cannon Research Institute, and it will focus on the outcomes of the FLEX Study.

The FLEX Study aims to investigate the 3-year outcomes of patients with HR+HER2-, genomically High Risk Luminal B-Type early breast cancer who received chemotherapy either with taxane and cyclophosphamide (TC) or with anthracycline plus TC (AC-T). This prospective, non-randomized, observational study (NCT03053193) employs both MammaPrint and BluePrint® genomic assays to determine tumor subtypes.

The results from the study indicate that patients with MammaPrint H1 Luminal B-Type tumors had comparable 3-year outcomes when treated with either TC (97.1%) or AC-T (95.3%). This suggests that patients classified as H1 may avoid the toxicity associated with anthracycline treatments. Conversely, patients with MammaPrint H2 Luminal B-Type tumors exhibited significantly better relapse-free survival rates when treated with AC-T (97.7%) compared to those treated with TC alone (86.4%). This underscores that MammaPrint H2 tumors benefit from incorporating an anthracycline into their adjuvant chemotherapy regimen.

Dr. O'Shaughnessy commented on the importance of tailoring treatment to a patient’s tumor biology to optimize outcomes and quality of life. She emphasized that MammaPrint's role in guiding treatment planning is validated by these new data, enhancing precision in identifying patients more responsive to specific systemic therapies.

Dr. William Audeh, Chief Medical Officer at Agendia, highlighted the significance of the FLEX research platform in evaluating different aspects of breast cancer during diagnosis and treatment. He noted that this study provides preliminary insights into the optimal chemotherapy regimens for MammaPrint High Risk tumors, reinforcing MammaPrint's clinical utility in treatment selection.

Additional data supporting MammaPrint’s role in treatment selection will be presented from the ISPY2 trial, indicating that MammaPrint H2 tumors share molecular and clinical characteristics with triple-negative breast cancer. This information is pivotal for optimizing treatment plans for patients with HR+/HER2-negative early-stage breast cancer.

Agendia continues to share updates throughout the ASCO conference on its social media platforms.

About Agendia
Agendia is a leading firm in precision oncology, focusing on early-stage breast cancer. Established in 2003 in Amsterdam and headquartered in Irvine, California, Agendia provides advanced genomic assays like MammaPrint® and BluePrint® to inform personalized treatment plans. These assays enable clinicians to identify the most effective treatment strategies, minimizing the risk of over- or under-treatment. The company’s state-of-the-art laboratory and commitment to ongoing research, particularly through the FLEX Study, aims to revolutionize breast cancer management.

About MammaPrint
MammaPrint® is an FDA-cleared gene expression profiling test that assesses the risk of early-stage breast cancer spreading. It analyzes 70 key genes to stratify risk into four categories: UltraLow, Low, High 1, and High 2, providing critical insights to tailor treatment plans, including chemotherapy and endocrine therapy.

About BluePrint
BluePrint® is a gene expression profiling test that identifies the driving forces behind a tumor’s growth, categorizing it as Luminal-type, HER2-type, or Basal-type. This classification informs distinct treatment pathways, helping optimize and personalize treatment plans from the earliest stages of breast cancer care. BluePrint® evaluates the activity of 80 key genes and can detect misclassified aggressive tumors, ensuring appropriate treatment from the start.

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