• At the 2023 ASCO® Annual Meeting, Agendia will present data that demonstrates women within MammaPrint’s highest risk category have the strongest sensitivity to chemotherapy and more aggressive tumor types, guiding escalated care plans for improved outcomes
• MammaPrint is the only gene expression profiling test with refined subcategories for risk of distant metastasis to inform more personalized treatment

At the 2023 ASCO Annual Meeting, Agendia, Inc., a gene expression profiling company advancing personalized early-stage breast cancer care, will present data that proves MammaPrint can predict chemotherapy sensitivity in women with early-stage, HR+HER- breast cancer. The research examined the clinical utility of MammaPrint’s two High Risk subcategories, High 1 (H1) and High 2 (H2), as an indicator of a woman’s predicted response to chemotherapy and five-year outcomes, in combination with BluePrint’s® molecular subtyping, to guide treatment decisions. The study found that women with H2 risk tumors are more likely to respond to chemotherapy and have aggressive, Basal-type tumors compared to women with H1 risk tumors. This data highlights the critical role MammaPrint and BluePrint play in identifying women with the highest risk tumors as early as possible to optimize and personalize treatment planning and improve their chance of survival.

While other gene expression profiling tests may lump women into broad-strokes risk groupings, MammaPrint is the only test that further subcategorizes both low risk (Low and Ultra Low), and high risk (H1 and H2) [1,2]. Tumors in each subcategory vary in their response to chemotherapy and deserve of a distinct treatment regimen [3,4,5]. These distinguished risk groups empower clinicians to further refine their treatment recommendations and confidently de-escalate or escalate therapy.

“Hearing that you have a high-risk tumor is scary news for any woman with early-stage breast cancer. Our ability to inform treatment decisions for high-risk tumors means we can avoid under or overtreating patients, and instead put them on the right path toward recovery at the right time,” said William Audeh, MD, Chief Medical Officer of Agendia. “There’s a sense of empowerment that comes with this additional insight and through our tests, patients and their care teams get the most refined, personalized answers to the multitude of questions surrounding an early-stage breast cancer diagnosis.”

Agendia’s poster presentation, “MammaPrint Index as a predictive biomarker for neoadjuvant chemotherapy response and outcomes in patients with HR+HER2- breast cancer in NBRST” will highlight the following results:

• H2 is a distinct, higher-risk category than H1, with a significantly higher percentage of ER+Basal subtype tumors. Of 327 women with MammaPrint High Risk tumors, 61% had H1 tumors, and 39% had H2 tumors. Within H2 tumors, 63% were Basal-type, compared to only 2% of H1 tumors.
• H2 tumors are almost four times more sensitive to chemotherapy than H1 tumors. 23% of H2 tumors responded to chemotherapy, compared to only 6% of H1 tumors.
• A woman’s menopausal status did not impact her response to chemotherapy. Despite what other studies have suggested, there was no significant difference in chemotherapy sensitivity among premenopausal and postmenopausal women across both high-risk groups.
• Women with H1 or H2 tumors who achieved a complete response to chemotherapy had similar outcomes. H2 tumors with residual cancer had the worst five-year outcomes. Women with H1 and H2 tumors who responded to chemotherapy both had a 5-year distant metastasis free survival (DMFS) of around 81%. For those with residual disease, H1 tumors had a 5-year DMFS of 77%, and H2 tumors had a 5-year DMFS of 65%.

"Refining prognosis and prediction of response to chemotherapy will help push more patients toward appropriate treatment. In light of the high proportion of H2 cancers being Basal subtype and carrying a worse prognosis if they do not get a complete response, it is not hard to envision that perhaps all H2 cancers should be treated more aggressively with the addition of immunotherapy to their chemotherapy,” said Peter Beitsch, MD, Surgical Oncologist, Dallas Surgical Group.

Agendia’s comprehensive gene expression profiling platform is the only one that can inform a woman’s full treatment regimen. Beyond determining her predicted response to chemotherapy, Agendia’s MammaPrint and BluePrint deliver consistent insights into the optimal timing and duration of a variety of therapies, so providers, together with their patients, can confidently map out a personalized treatment plan that maximizes their survival rate while minimizing damage to their quality of life.

Agendia will also present two additional posters that demonstrate its commitment to advancing research in underserved populations, and an oral presentation on the ability of genomic biomarkers to predict a woman’s response to immunotherapy. Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

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. 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.

[1] Cardoso, F., et al. (2016). 70-gene signatures as an aid to treatment decisions in early-stage breast cancer. NEJM, 375, 717-729. https://www.nejm.org/doi/full/10.1056/nejmoa1602253

[2] Piccart, M., et al. (2021). 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncology, 22(4), 476-488. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00007-3/fulltext

[3] Van’t Veer, L., et al. (2018). MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~ 1000 breast cancer patients in the I-SPY 2 TRIAL. Presented at 2018 EORTC-NCI-AACR Symposium on Molecular Targets and cancer Therapeutics.

[4] Huppert, L., et al. (2022). Pathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 trial. Journal of Clinical Oncology, 40 (16, Suppl.), 504. https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.504

[5] Pusztai, L., et al. (2021). Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial. Cancer Cell, 39(7), 989-998. https://www.cell.com/cancer-cell/fulltext/S1535-6108(21)00275-0

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