CA-AGENDIA

Agendia, Inc. , a world leader in precision oncology for breast cancer, today announced that data from FLEX, the large-scale, prospective, observational breast cancer study, has been selected for presentation in six posters during the 2020 San Antonio Breast Cancer Symposium (SABCS 2020). The posters, being presented at different sessions throughout SABCS 2020, focus on underrepresented or underserved populations or types of breast cancer.

“FLEX could be one of the most valuable, impactful, flexible, and inclusive studies in breast cancer research to date,” said Laura Lee, M.D., Surgical Oncology Specialist at Desert Comprehensive Breast Center at Desert Regional Medical Center, and first author of the FLEX update poster. “These data reveal that tumor heterogeneity goes beyond ethnicities and underscores the importance of gene expression analysis as a tool for bringing those differences to light. We are enrolling patients representing all of the clinical and genomic subtypes from a broad spectrum of community and academic sites. As researchers, we are excited by the opportunity to access this real-world data set where we can ask meaningful clinical questions and then see what the data tell us.”

Highlights from the FLEX data are as follows:

• [OT12-01] The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer outlines updates from the FLEX study, a registry intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer. With purposefully-wide inclusion criteria, the registry aims to enable researchers to investigate the differences and trends between breast cancer subgroups and allow focus on smaller, more diverse patient populations, which have traditionally been challenging to recruit in sufficient numbers for clinical trials.

• [PS7-69] Molecular profiles and clinical-pathologic features of Asian early-stage breast cancer patients assesses the clinical, pathological and molecular profiles from self-reported Asian breast cancer patients (AS), in comparison with age-matched Caucasian (CA) and African American patients (AA), to evaluate the influence of Asian ancestry on differential gene expression in breast tumors. The analysis revealed different gene set enrichment patterns in tumors of AS compared with CA and AA, which may contribute to differential clinical outcomes and highlights the importance of including patients of Asian ancestry in genomic breast cancer research. Additionally, the poster found more differentially-expressed genes in MammaPrint High Risk tumors between AS and AA patients than between AS and CA patients, reinforcing the need for additional research to evaluate the influence of ancestry on differential gene expression in breast tumors.

• [PS14-11] Differential gene expression analysis and clinical utility of MammaPrint and BluePrint in male breast cancer patients compares the under-researched population of male breast cancer patients (MaBC) to that of female breast cancer patients (FBC) to determine whether significant molecular biological differences exist between the two groups. Utilizing the MammaPrint and BluePrint assays, the analysis suggests that distinct biological pathways between the two groups indicate an upregulation of estrogen response and MTORC1 signaling in MaBC compared to FBC, and warrants further investigation to assess clinical outcomes.

• [PS7-68] Racial disparities within Basal-type breast cancer: clinical and molecular features of African American (AA) and Caucasian (CA) obese patients investigates differential gene expression between two ethnic groups with clinically-matched comorbidities, in this case diabetes and obesity, who have been diagnosed with Basal-type breast cancer. The goal is to determine the influence metabolic factors or patient ancestry may have on outcomes as these data mature. Currently, the analysis suggests that there are further disparities in AA and CA patients beyond those attributable to clinical and social factors, which may help identify novel treatment approaches in the future.

• [PS18-03] Differential gene expression in Luminal-Type invasive lobular carcinoma and invasive ductal carcinoma by MammaPrint risk stratification assesses differential gene expression between invasive lobular carcinomas (ILC) and invasive ductal carcinomas (IDC) in a large, age-matched patient subset using MammaPrint and BluePrint to stratify those populations. The analysis suggests that when evaluated by MammaPrint, about one-third of ILCs were classified as MammaPrint High Risk, displaying heterogeneity in High Risk tumors and MammaPrint’s ability to predict unfavorable survival outcomes for patients with this type of tumor. The study results underscore the ability of FLEX to enroll smaller patient populations on a larger scale, enabling further investigation and the opportunity to provide targets for treatment optimization for those patients.

• [PS18-05] Using BluePrint to elucidate the molecular heterogeneity of triple negative breast cancers assesses triple negative breast cancers (TNBC) to understand the relationship between gene expression signatures provided by BluePrint and immunohistochemistry-defined TNBC. The analysis suggests that BluePrint enables further stratification of TNBC tumors, moving this type of cancer into different subgroups and shedding new light on TNBC tumor heterogeneity that may one day impact treatment planning.

“TNBC has long been a difficult diagnosis for both patients and physicians because of its aggressive nature. Very often, there is no time and no room for trial and error in the treatment decision-making process so there is a lot of pressure to get things right,” said Virginia Kaklamani, M.D., Co-director of SABCS, leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, Professor of Medicine in the Division of Hematology/Oncology at UT Health San Antonio, and first author on the poster focusing on TNBC tumors. “By leveraging BluePrint for the evaluation and stratification of TNBC tumors, we hope to be able to tease out the differences in this challenging type of cancer – which can sometimes include more than one activated genomic pathway – to determine where and when to hit it hardest for the benefit of our patients.”

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage breast cancer patients and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient.

MammaPrint^® , the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint^® , the 80-gene molecular subtyping assay, is the only commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint^® and BluePrint^® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings.

Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.

Agendia’s assays can be ordered on core biopsies or surgical specimens to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com .

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