Agendia Presents Data from Innovative FLEX Study at ASCO 2021 Showing MammaPrint and BluePrint Utility in Wide Variety of Patient Populations

• Whole transcriptome analysis of ER+ breast cancers showed no substantial difference in gene expression between tumors from women younger than 50 and women older than 50
• Whole transcriptome analysis confirms that genomic expression profiles from BluePrint ER+ Basal tumors and ER- Basal tumors are very similar, providing clinically actionable information to guide neoadjuvant treatment decisions
• FLEX real-world registry to enroll 10,000 patients with breast cancer by end of 2021, with ultimate goal to enroll 30,000 total

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a world leader in precision oncology for breast cancer, announced that new data from the first-of-its kind, national FLEX registry was debuted today at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

The FLEX study is led by clinicians across the United States and utilizes a shared study infrastructure to develop and investigate hypotheses for targeted patient subsets based on full transcriptome data, and annotated with over 800 clinical data elements. FLEX allows for diverse groups of patients and their physicians to participate in a clinical trial even if they are not living near a major research center.

“FLEX has continued to show its value in the enormous breadth of growing data we as oncologists and researchers can access,” said Cynthia X. Ma, MD, PhD, oncologist and FLEX national PI at Washington University School of Medicine in St. Louis. “The collaborative nature of the registry gives physicians the chance to investigate the hypotheses formed in our real-world practices on a national level, to answer questions of both clinical importance and scientific interest. The depth and clinical significance of our findings are felt throughout the breast cancer community.”

At the virtual ASCO 2021 conference, Agendia and its research collaborators provided a general update on the currently enrolling FLEX trial in a poster titled “The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer.”

The power of FLEX to address relevant and pressing clinical questions was illustrated by data presented in a poster entitled “Whole transcriptome analysis comparing HR+ HER2- breast cancer tumors from patients <50 years and >50 years.” The study showed that whole transcriptome analysis identified no substantial differences in gene expression between HR+/HER2- tumors in women with breast cancer, regardless of their age (over or under 50 years old). The data support the likely explanation that the apparent age-dependent benefit of chemotherapy in women younger than 50 with genomically Low Risk cancer, observed in recent trials, is not due to intrinsic biological differences in breast cancer, but rather to differences in the indirect effects of chemotherapy on the patient. These findings reinforce the essential need for shared decision making between a patient and her physician using the patient’s genomic expression profile as part of an informed treatment plan.

“We are excited to present an age-based analysis of the genomics in early stage breast cancer which has garnered so much attention in the last couple of years,” said Cathy Graham, MD, FACS, Director of Breast Surgery, Glenn Family Breast Center of Winship Cancer Institute at Emory Saint Joseph’s Hospital, and first author of a FLEX poster focused on age-based analysis. “The trend that has emerged, which suggests that chemotherapy benefit seen in younger women may be a side effect of ovarian suppression – not necessarily the cytotoxic effects of the chemo on a tumor – is seen again in these results and must be considered when potentially less-aggressive alternatives are available.”

Additional data of clinical significance for high risk ER+ breast cancer were presented by FLEX investigators including Joyce O’Shaughnessy, MD, Co-Chair of Breast Cancer Research and Chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center and for The US Oncology Network, and a member of the Scientific Advisory Board for US Oncology Research Network, in the poster titled “Molecular profiles of genomically High Risk ER+ HER2- breast cancer tumors classified as functionally Basal or Luminal B by the 80-gene signature.” This study outlined the identification by BluePrint of a subgroup of high risk ER+ tumors that are genomically Basal, and showed that analysis of whole transcriptome expression profiles reveals these cancers to be biologically closer to ER- Basal (and triple negative breast cancer) than ER+ Luminal cancers. ER+ Basal tumors may therefore require more aggressive treatment than ER+ Luminal tumors, confirming that BluePrint provides clinically actionable information beyond pathological subtyping and may guide neoadjuvant treatment decisions.

A further study from the FLEX database analyzed the correlation between a traditional poor prognosis pathology feature, lymphovascular invasion (LVI), and gene expression patterns. The study, titled “Gene expression associated with lymphovascular invasion and genomic risk in early-stage breast cancer,” was presented by Nina D’Abreo, MD, medical director, breast program, Winthrop University Hospital, Perlmutter Cancer Center, and her colleagues, and showed that the potential prognostic information gained from the presence or absence of lymphovascular invasion (LVI) gene expression is likely already captured by MammaPrint and BluePrint. Importantly, presence or absence of LVI in MammaPrint Low Risk cancers was not associated with any discernible differences in whole transcriptome gene expression. LVI is currently excluded from most breast cancer clinical risk assessments, and while further studies will assess clinical outcomes, these data suggest that MammaPrint and BluePrint may be able to address a current gap in stratification of early stage breast cancers.

Agendia’s large-scale, prospective FLEX study continues to provide a rich source of data from real-world evidence in one of the most dynamic and inclusive study designs in breast cancer research to date, underscoring the company’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients.

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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