CA-AGENDIA-INC

Agendia, Inc. , a world leader in precision oncology for breast cancer, announced today that an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting revealed new data from the national FLEX registry that identify differences in tumor biology between ethnic groups that can lead to meaningful treatment decisions, reinforcing the need for appropriate representation of diverse patient populations in breast cancer studies.

A major theme of this year’s ASCO meeting centers around disparities in care and outcomes, which Agendia’s FLEX study aims to combat by prospectively enrolling 30,000 patients from various ethnicities, ages and demographic groups representative of the total breast cancer population. The data presentation from this study, “Disparities within Luminal breast cancer: clinical and molecular features of African American and non-Hispanic White patients ,” delivered by first author of the study Kent Hoskins, MD, Co-Leader of the Breast Cancer Research Group and Director of Cancer Genetics at the University of Illinois Cancer Center, details significant biological differences in luminal breast tumors from African American and non-Hispanic White women, suggesting that shared adverse socioeconomic exposures and/or genetic ancestry may be driving disproportionately aggressive tumor biology in African American women. This finding further underscores the need for inclusion of diverse patient groups in clinical trials to ensure equity in drug development.

“The data presented at ASCO 2021 show significant transcriptomic differences between Luminal tumors from African American and non-Hispanic White patients, seen even more starkly as our study controlled for age, obesity, and genomic classification,” said Dr. Hoskins. “The data show ER+ breast cancers in African American women more often had upregulation of the mTOR pathway and cell cycle genes, which require different treatment approaches than other ER+ breast cancers. These data tell us that we desperately need proper representation of diverse populations in clinical trials, and future studies focused on the efficacy of these agents specifically in African American women with breast cancer, so that all patients can benefit from precision medicine, tailored to them, and accounting for their ancestry and genomic profiles.”

Additional data from Agendia regarding breast cancer in African American women was shared in an abstract titled “Genomic risk classification by the 70-gene signature and 21-gene assay in African American, early-stage breast cancer patients. ” This study was triggered by recent research showing less accurate prognostic performance of OncotypeDX in African American women with early stage breast cancer. The abstract compared MammaPrint and OncotypeDX results in a cohort of African American women with ER+ breast cancer, and observed an overall discordance of 51% between the two tests in African American patients; notably, of tumors with a TAILORx intermediate risk score (11-25), 61% were classified as MammaPrint High Risk. Combined with previously published data in African American patients, 57% of OncotypeDX low risk score tumors are re-classified as MammaPrint High Risk, suggesting that OncotypeDX results could be less accurate in African American patients.

In addition, recent data indicate that African American patients who receive a low or intermediate OncotypeDX risk score have higher recurrence rates and lower survival than Caucasian patients with early stage breast cancer with the same risk score, a difference that can have meaningful clinical implications and requires further investigation.¹

“It is essential that genomic tests either work consistently across diverse groups of patients, or have the ability to be calibrated to do so,” said Patricia Robinson, MD, Associate Professor of Hematology and Oncology at Loyola University Medical Center, and Assistant Dean of Diversity, Equity and Inclusion at the Strich School of Medicine, “We cannot be using genomic tests that work for some people and not others, or accepting that the tests, which offer such crucial information, work better for some than for others. While the clinical evaluation of the discrepancy between OncotypeDX and MammaPrint may be ongoing, this data still captures the diversity of pathways driving tumor metastasis, and reinforces the importance of proper representation in trials and in test development and optimization.”

Agendia’s large-scale, prospective FLEX registry continues to highlight data from real-world practices in one of the most flexible and inclusive studies in breast cancer research to date, playing an important part in the company’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 patients with early stage breast cancer 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 patients with breast cancer 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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¹ Hoskins, Kent F., et al. “Association of Race/Ethnicity and the 21-Gene Recurrence Score With Breast Cancer–Specific Mortality Among US Women.” JAMA Oncology, vol. 7, no. 3, 2021, p. 370., doi:10.1001/jamaoncol.2020.7320.

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