Agendia Level 1B Evidence Shows MammaPrint® is the First and Only FDA-cleared Gene Expression Profiling Test to Predict Benefit from Extended Endocrine Therapy in Early-Stage Breast Cancer Patients

• Late-breaking abstract at the 2022 San Antonio Breast Cancer Symposium (SABCS) will illustrate MammaPrint’s ability to identify strongest candidates for extended endocrine therapy among HR+HER2- post-menopausal women

Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, today announced it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET). The study, which analyzed MammaPrint results of over 500 patients enrolled in the IDEAL trial, proved MammaPrint test results can effectively identify which post-menopausal, hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients will benefit from five years of EET. This research highlights the value of advanced gene expression profiling tests to gather personalized insights that inform a patient’s treatment plan beyond solely predicting their response to chemotherapy.

Prescribing EET with more precision can not only help avoid unnecessary patient suffering, but also give those who are most likely to benefit from EET the encouragement to remain adherent. Agendia’s research found MammaPrint can identify which HR+ post-menopausal patients are at risk of late distant metastasis and would benefit most from EET, and for whom treatment compliance is important. Additionally, MammaPrint helps identify those who will realize minimal to no benefit, offering patients the power of choice when discussing their treatment plan with their provider.

Laura van ‘t Veer, PhD, Co-Inventor of MammaPrint and a Professor of Laboratory Medicine and Director of Applied Genomics at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center, will present during SABCS on December 9^th at 12pm CT. She will highlight the following findings among HR+ post-menopausal women with early-stage breast cancer:

• Tumors classified with a MammaPrint Low Risk result exhibited the largest benefit of five additional years of EET compared to 2.5 years, with 9.8% improvement for distant metastasis, 9.8% improvement for recurrence free interval, and 8.8% improvement for breast cancer free interval.
• In contrast, tumors with a MammaPrint High Risk result do not benefit from five additional years of EET because they exhibit an early recurrence risk profile, and therefore have reduced sensitivity to the therapy after the initial 5 years of treatment.
• Tumors with a MammaPrint UltraLow Risk result also do not benefit from EET due to their excellent prognosis and low risk of late recurrence.
• MammaPrint test results have now been used in level 1B evidence for extended endocrine treatment decisions, providing high confidence of its net benefit that providers and patients can rely on when making EET treatment decisions.

“The results of this study reaffirm the critical role MammaPrint plays in guiding treatment decisions with the unprecedented precision that patients deserve. Physicians and patients need to be equipped with gene expression profiling solutions that can offer a comprehensive view of their tumor’s predicted response to various therapies, not just chemotherapy,” said Dr. Laura van ‘t Veer. “No patient should have to be on a difficult therapy longer than necessary, and those who will benefit from a longer duration need encouragement to stay on track. Agendia is empowering women with need-to-know answers and physicians with tools to guide shared decision-making.”

“Genomic information continues to transform the way we deliver cancer care, and this latest research is no exception. Being able to decipher which patients see a significant benefit and which can forgo EET is a monumental accomplishment in our aim toward precision medicine,” said Dr. Gerrit-Jan Liefers, surgeon and head of the Geriatric Oncology Group at Leiden University Medical Center, and lead author of the study.

To learn more about Agendia’s solutions being showcased at booth #315 at SABCS, visit https://agendia.com/our-tests/. Follow Agendia on Twitter, Facebook and LinkedIn for updates throughout the conference.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes 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 the biology underlying 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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