CA-AGENDIA

Agendia, Inc. , a world leader in precision oncology for breast cancer, today shared data demonstrating the ability of MammaPrint^® and BluePrint^® to predict patient outcomes following neoadjuvant chemotherapy (NAC) at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021).

The poster, titled MammaPrint and BluePrint are prognostic of outcome following neoadjuvant chemotherapy , presents findings that indicate MammaPrint and BluePrint accurately correlated with chemosensitivity and outcomes in NAC-treated patients. The research was conducted in collaboration with Cedars-Sinai Medical Center.

Notably, approximately 1 in 4 tumors which were MammaPrint High Risk (Luminal B) prior to NAC became MammaPrint Low Risk (Luminal A) when the post-treatment tissue was analyzed. Patients with reclassified MammaPrint Low Risk tumors had improved five-year outcomes compared to patients that remained High Risk after treatment. These data signal a role for serial genomic testing to determine proper classification of breast cancer tumors following NAC treatment in order to appropriately manage a woman’s future treatment plan and prognosis.

“By analyzing MammaPrint and BluePrint on pre- and post-NAC tissue samples for those with residual disease, we unlock new insights about their clinical utility and potential impact on treatment decisions given the biological changes that may occur following initial intervention,” said Alice P. Chung, MD, Division of Surgical Oncology, Department of Surgery, Cedars-Sinai Medical Center. “The importance of accurate genomic classification of a tumor is crucial, especially in the context of these findings where 1 in 4 High Risk tumors became Low Risk – insights which can significantly affect our treatment planning discussions with patients.”

The analysis presented at SABCS 2021 features data from 128 women (median age 50) with stage I-III early breast cancer (EBC), of any clinical subtype, diagnosed from 2007-2016 who received NAC at Cedars-Sinai Medical Center. Among 111 pre-treated tumors, MammaPrint High Risk tumors had a significantly higher pathological complete response (pCR) rate than Low Risk tumors. Amongst tumors that had discordant MammaPrint results between pre- and post-treatment samples, the only change observed was from High Risk to Low Risk. BluePrint results were very consistent between pre- and post-NAC samples (92% concordance) with reclassification only occurring in the HER2-Type cohort, consistent with the known heterogeneity in clinically HER2-positive tumors.

“Neoadjuvant chemotherapy is the standard of care for the initial treatment of certain types of breast cancer, and for many women, the clinical response to therapy is thought to carry prognostic implications. This study illustrates the additional information provided by our genomic assays regarding response to therapy and prognosis,” said William Audeh, MD, Chief Medical Officer at Agendia and a study author. “While changes in the MammaPrint Risk index with treatment are clearly associated with outcome, it is also important to note the consistency of BluePrint results pre- and post- treatment with neoadjuvant chemotherapy. These data further demonstrate the prognostic accuracy of the assays and confirm the importance of genomic information in our quest to identify better biomarkers in patients treated with neoadjuvant chemotherapy.”

Future studies will study the effect of NAC on the breast cancer transcriptome and its association with clinical outcomes.

About Agendia

Agendia is a mission-driven company focused on enabling optimized treatment planning by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes and quality of life for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint^® and BluePrint^® provide a holistic view of an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com .

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