Agendia presents data from the FLEX Real World Evidence Test on seven posters at ASCO 2022, showing the power of its breast cancer genome project for 30,000 patients

IRVINE, California & AMSTERDAM – (BUSINESS WIRE) – Agendia, Inc., a commercial company focused on improving outcomes for breast cancer patients worldwide by providing next-generation diagnostic and information solutions to physicians and patients to inform them about optimized treatment decisions, announced today to present seven posters derived from FLEX Trial, a true, multicenter, prospective, observational study of breast cancer on Annual Meeting of the American Society of Clinical Oncology (ASCO) 2022

One of the Agendie posters selected for oral discussion, with the title Complete transcriptome analysis of HR + breast cancer in black women classified by BluePrint as basal type [Reid, S., et al.], will present the findings of a racially diverse cohort and consequent transcriptomic analysis showing that hormone receptor (HR +) / basal tumors are biologically similar to triple-negative breast cancer (TNBC) tumors, regardless of race, demonstrating the importance of biotyping tumor. determine the optimal course of treatment. BluePrint® also found racial differences in the proportion of HR + / basal tumors, indicating an almost doubling of such tumors among black women, highlighting the need for diverse representation in clinical trials, which is a feature of the FLEX trial.

“Using BluePrint analysis, we can discover new insights into the expression of genes for HR + / Basal breast cancer tumors that are traditionally more aggressive, higher rates, and disproportionately affecting black women compared to white women,” said Sonya Reid, MD, MPH. , Department of Medicine, Vanderbilt University Medical Center. “The FLEX Trial’s diverse collection of diverse genomic patient profiles uniquely allows such sub-studies to be conducted, helping researchers better support their patients from all racial and ethnic backgrounds by further classifying breast cancer tumors.”

These data are based on the findings presented at Symposium on Breast Cancer in San Antonio 2021whose author is also dr. Reid, who showed MammaPrint® in BluePrint® more robustly identify differences in more aggressive breast cancers in black-and-white women that go beyond clinical factors, emphasizing the fundamental importance of genomic classification and tailored treatment planning.

In addition, Agendia will present several sub-studies highlighting the FLEX Trial approach to cancer research by promoting the generation of effective data aimed at redefining cancer treatment. The company believes that this patient-centered design and the national network of participating sites supported by Agendia will allow its research-initiated sub-studies to generate significant results with the potential to advance science such as those were presented at ASCO 2022:

  • Clinical implications for patients with inconsistent Oncotype and MammaPrint results [Socoteanu, M., et al.] recalls the findings of the IMPACT trial, which showed that MammaPrint and BluePrint help plan treatment and increase the confidence of doctors. In an effort to examine consistency between genomic tests, the researchers analyzed treatment outcomes for patients who received both MammaPrint and BluePrint results as well as OncotypeDx in the FLEX trial:

    • Of the 722 patients, 49% observed inconsistent results with the possibility of a negative clinical effect. This includes 27% of those who may be undertreated, 6% potentially overtreated and 10% who may not be able to reduce endocrine treatment to two years based on the MammaPrint Ultra Low genomic risk assessment. Of the 114 high-risk MammaPrint-compliant tumors, 14% were genomically classified as basal and probably require more aggressive chemotherapy than is commonly used in estrogen-positive (ER +) positive breast cancer.

    • Together, these analyzes showed that more than half of the patients in this cohort were at potential risk of under- or over-treatment if they received the OncotypeDx test as a stand-alone test. Discrepancies between OncotypeDx recurrence estimates and MammaPrint scores with BluePrint scores most often lead to the possibility of under-treatment if reliance is based on recurrence assessment, which poses a high risk to the patient as insufficient treatment can lead to incurable metastatic recurrence.

  • Analysis of the entire tumor transcript with inconsistent Oncotype and MammaPrint results in the FLEX trial [Socoteanu, M., et al.] they also examined differences in the quality of OncotypeDx Recurrence Score scores compared to MammaPrint scores, this time by assessing genomic diversity within the classification of each test. The analysis revealed great genomic diversity in the OncotypeDx Recurrence Score Intermediate group, while the opposite showed that MammaPrint further categorizes cases into more genomically rich and different categories, allowing for more precise treatment pathways based on individual tumors.
  • Genomic signature study for MAF transcription factor gene multiplication and lack of bisphosphonate benefits in early breast cancer [Nasrazadani, A. et al.] provides full transcript analyzes suggesting that breast cancer tumors can be identified by unique gene expression. In this study, researchers used the MammaPrint / BluePrint platform to identify a set of 57 genes that could predict MAF replication status, which could allow the women’s care group to potentially predict a lack of benefit from adjuvant bisphosphonate treatment. In addition, these results suggest that more thorough mining of the entire genome provides expanded insight and may shed light on new biomarkers that were previously unknown.
  • Distribution of molecular subtypes of breast cancer within receptor classifications: lessons from the I-SPY2 trial and the FLEX registry [Cha, J., et al.] Suggests that the Breast Cancer Research Community promote science further and work with the NCI’s Surveillance, Epidemiology and Outcome Results (SEER) program to update its immunohistochemical (IHC) labels to avoid overlap with molecular subtype nomenclatures and to include more modern classifications if available. The results of the study show that the SEER database, which uses IHC codes, does not accurately identify genomic subtypes with its notes. In fact, categorizations in the population registry contradicted MammaPrint and BluePrint results in 52% of I-SPY2 Trial cases and 43% of FLEX Trial cases, underscoring the growing importance of molecular subtyping for treatment information and epidemiological research.
  • Definition of transcriptome profiles of early stages of mucinous breast cancer: FLEX sub-study [Sivapiragasam, A., et al.] revealed that although mucinous breast cancer (MuBC), a rare subtype of invasive ductal carcinoma (IDC) accounts for less than 2% of all breast cancers, is often expected to have a low clinical risk and a favorable prognosis, new genomic testing has shown half of patients observed in the study were actually classified as MammaPrint high risk. Examining the transcriptome profiles, the findings showed that the low-risk MuBC MammaPrint is biologically different from the MammaPrint Low Risk IDC, which provides new evidence as to why there are more favorable predictions. The results also showed that MammaPrint High Risk MuBC and High Risk IDC are very genomically similar and could benefit from chemotherapy, providing additional clarity to guide specific treatment among these subtypes of breast cancer.
  • FLEX, 30,000 Breast Cancer Transcripts Project: A Platform for Early Breast Cancer Research Using Full Genome Sets Combined with Clinical Data [Ma, C., et al.] shares data from 38 sub-studies launched by investigators – including five investigating racial differences – approved under the FLEX Real World Evidence Trial (NCT03053193). Since the start of the trial in 2017, FLEX has included 10,000 patients in more than 109 locations with a diverse data set designed to meet the needs of historically underrepresented breast cancer patients.

“These new findings, presented at ASCO 2022, show the breadth of the FLEX research platform for identifying and evaluating many different complexities of breast cancer biology at diagnosis that can facilitate more accurate and individualized treatment recommendations,” said William Audeh, MD, chief medical officer. Agenda. “Agendie’s commitment to broadening our understanding of breast cancer to improve outcomes in women with breast cancer is astounding, as exemplified by the FLEX Real World Evidence Trial. FLEX has great potential to expand the use of genomic information through tests such as MammaPrint, BluePrint and new proprietary Agendia signatures, which could lead to models that change breast cancer care practices to improve outcomes for women with breast cancer.

Agendia will be sharing updates at the conference Twitter, Facebook in LinkedIn pages.

About the Agenda

Agendia is a mission-focused commercial company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and informational solutions that can be used to improve outcomes for breast cancer patients worldwide. The company currently offers two commercially available genomic profiling tests to help surgeons, oncologists and pathologists tailor treatment to women at critical points of intervention throughout the patient’s path.

MammaPrint® is a prognostic test of 70 genes, which together with other clinical and pathological factors determines the risk of recurrence of breast cancer in a particular patient. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis, and possible response to systemic treatment. Together, MammaPrint® in BluePrint® they provide a holistic view of the biology on which an individual patient’s breast cancer is based, allowing physicians to objectively choose the best treatment plan.

For more information on Agendia tests and ongoing testing, visit www.agendia.com.

Elvira Parkinson

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