On May 31, 2024 Agendia, Inc. reported that it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, taking place in Chicago, IL. on June 3rd, 2024 (Press release, Agendia, MAY 31, 2024, View Source;Early-Stage-Breast-Cancer-at-2024-ASCO [SID1234643918]).
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The study presented by Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial, titled Elucidating the immune active state of HR+HER2- MammaPrint High 2 early breast cancer [Cobain, E., et al.] characterizes the underlying immune biology that mediates immune therapy response in early stage hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor negative (HER2-) breast cancer, categorized as MammaPrint High Risk 2 (MP H2) in patients enrolled in the prospective, observational FLEX Study (NCT03053193). This study builds upon the findings from the I-SPY 2 Trial, which showed that patients with MP High-2, HR+HER2- tumors have improved response rates when immunotherapy is added to standard neoadjuvant chemotherapy.
Using whole transcriptome analysis, researchers evaluated relative frequency of immune cell types, expression level of genes involved in antigen processing and presentation, and expression of immune checkpoint genes PD-1 and PD-L1. Results of the analysis showed that MP High-2 tumors had a significantly higher frequency of antigen presenting cells (APCs) (including activated dendritic cells and macrophages, CD4+ memory T cells, CD8+ T cells, memory B cells and antibody producing plasma cells) relative to High-1 tumors, highlighting an increased immune active state in High-2 tumors. The increased antigen presentation and presence of APCs, which are critical in activating T- and B-cells, may explain why High-2 tumors display improved response rates to immunotherapy. The data from this study suggests that early stage HR+HER2- High-2 tumors might benefit from the addition of immunotherapy to their chemotherapy treatment regimens. These findings support the rationale for the ongoing SWOG S2206 (NCT06058377) Trial, which is utilizing MP High-2 as a biomarker to select patients for neoadjuvant chemo-immunotherapy treatment.
"There is a great need for biomarkers beyond PD-L1 and tumor mutational burden that may predict clinical benefit from immunotherapy-based treatments. The recent CheckMate 7FL and KEYNOTE-756 studies demonstrated that there is a subset of patients with HR+HER2- early breast cancer that will benefit from immunotherapy, as both trials demonstrated an improvement in likelihood of pathologic complete response rates for those patients receiving neoadjuvant chemo-immunotherapy compared to chemotherapy alone," said Dr. Cobain. "However, we are aiming to take this a step further and refine the biomarkers that will allow for us to identify those patients most likely to benefit from this approach and avoid overtreatment. This is particularly important given the potential serious toxicities that can result from immunotherapy treatment."
"This study highlights the importance of understanding how the classification of tumors may determine different response rates to treatment and how this will inform breast cancer care going forward. With the FLEX Study, we are now able to not only look at clinical outcomes but also analyze whole transcriptome data to better understand how women with breast cancer respond to different treatment regimens and use this information to customize breast cancer treatment," said William Audeh, MD, MS, Chief Medical Officer of Agendia. "The data we’re sharing at 2024 ASCO (Free ASCO Whitepaper) further validates MammaPrint utility in identifying not only the question of chemo vs. no chemo, but also illustrates the ability of MammaPrint to identify tumors with increased immune activation, supporting the rationale for using MammaPrint High 2 as a selective biomarker for immunotherapy in SWOG S2206."