Agendia Presents Data from Innovative FLEX Study at ASCO 2021 Showing MammaPrint and BluePrint Utility in Wide Variety of Patient Populations
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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Westwicke/ICR Healthcare PR
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EIG-Led Consortium Closes $12.4 Billion Infrastructure Deal with Aramco18.6.2021 21:02:00 CEST | Press release
EIG,a leading institutional investor to the global energy sector and one of the world’s leading infrastructure investors, today announced the closing of its previously announced transaction with Saudi Arabian Oil Co. (“Aramco”), under which a consortium of investors acquired a 49% equity stake in Aramco Oil Pipelines Company (“Aramco Oil Pipelines”), a newly formed entity with rights to 25 years of tariff payments for oil transported through Aramco’s stabilized crude oil pipeline network. The EIG-led co-investment process in Aramco Oil Pipelines attracted a global group of leading institutional investors from China, the Kingdom of Saudi Arabia, Korea, the United Arab Emirates and the United States including, amongst others, Mubadala Investment Company, an Abu Dhabi Sovereign Investor, Silk Road Fund, Hassana and Samsung Asset Management. R. Blair Thomas, EIG Chairman and CEO, said: “We are pleased to have completed this transaction with Aramco, a preeminent global energy supplier. The
Moody's ESG Solutions: V.E provides Second Party Opinion on Desjardins’ Sustainable Bond Framework18.6.2021 18:13:00 CEST | Press release
Moody's ESG Solutions announced today that V.E has provided a Second Party Opinion (SPO) on Desjardins’ Sustainable Bond Framework. The framework will be used to finance and refinance projects tied to eight environmental categories and three social categories, including Renewable Energy, Green Buildings, and Affordable Housing. In V.E’s opinion, the framework is aligned with the four core components of the Green Bond Principles (2018) and the Social Bond Principles (2020). “In our assessment, the bonds issued via this framework will provide an ‘advanced’ contribution to sustainability objectives, as we see significant and consistent evidence that the proceeds will be allocated to environmentally and socially focused projects throughout Canada and several emerging markets,” said Patrick Mispagel, Managing Director – Sustainable Finance at Moody’s ESG Solutions. “We expect to see growth in sustainability efforts in North America in order to meet increasing global regulatory requirements
Potential sale of HSBC SFH (France): Signing of a Memorandum of Understanding18.6.2021 15:30:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION HSBC Continental Europe (‘HBCE’) has today signed a Memorandum of Understanding (‘MOU’) with Promontoria MMB SAS (‘My Money Group’), its subsidiary Banque des Caraïbes SA (the ‘Purchaser’) and My Money Bank (‘MMB’), regarding the potential sale of HBCE’s retail banking business in France. My Money Group, MMB and the Purchaser are under the control, directly or indirectly, of funds and accounts managed or advised by Cerberus Capital Management L.P. The potential sale includes: HBCE’s French retail banking business; the Crédit Commercial de France (‘CCF’) brand; and, subject to the satisfaction of relevant conditions, HBCE’s 3% ownership interest in Crédit Logement, its 100% ownership interest in HSBC SFH (France) (‘HSFH’), and the transfer of rights and obligatio
UFC® Names Lumen® the Official Metabolic Tracker of the UFC Performance Institute18.6.2021 15:30:00 CEST | Press release
UFC®, the world’s premier mixed martial arts organization, has named Lumen® the Official Metabolic Tracker of the UFC Performance Institute®. To launch the new partnership, select UFC athletes will be using Lumen as a tool to optimize their performance under the guidance of the nutrition team at the UFC Performance Institute (UFC PI). These athletes will have access to real-time metabolic data to help improve their nutrition, performance, and body composition through optimizing their metabolic health and flexibility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210618005278/en/ Dustin Poirier and Lumen (Photo: Business Wire) “The UFC PI strives to support athletes in fueling their body to achieve championship performances while also maintaining optimal health, all while meeting the weight management demands of mixed martial arts,” said Clint Wattenberg, UFC PI Director of Performance Nutrition. “Metabolic health and metabo
Sale of Retail Banking Business in France18.6.2021 15:30:00 CEST | Press release
HSBC Continental Europe (‘HBCE’) has today signed a Memorandum of Understanding (‘MOU’) with Promontoria MMB SAS (‘My Money Group’), its subsidiary Banque des Caraïbes SA (the ‘Purchaser’) and My Money Bank (‘MMB’), regarding the potential sale of HBCE’s retail banking business in France. My Money Group, MMB and the Purchaser are under the control, directly or indirectly, of funds and accounts managed or advised by Cerberus Capital Management L.P. Commenting on the Potential Transaction, Jean Beunardeau, HBCE CEO said: “This potential transaction is an important step towards achieving our strategic goal of being a leading wholesale bank in Continental Europe for Corporate and Investment Banking, Markets and Private Banking, anchored in Paris, connecting our customers to HSBC’s global network, and providing access to Continental Europe for HSBC’s customers around the world. As importantly, this potential transaction would allow HSBC’s French retail banking business to be sold to an expe
Hilton Doubles Down on Las Vegas Growth with Rapidly Expanding Portfolio and Grand Return to the Strip18.6.2021 15:07:00 CEST | Press release
After revolutionizing the Las Vegas hospitality experience decades ago, Hilton is building on its storied legacy in time for the return to travel by almost doubling its presence in the sought-after global destination over the past three years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210618005335/en/ Resorts World Las Vegas – Exterior (Photo: Business Wire) The company is slated to have more than 30 hotels and over 11,000 rooms across 12 brands in the market by the end of 2021. On the heels of Virgin Hotels Las Vegas, CurioCollection by Hilton’s June opening celebration, and just weeks before the anticipated debut of Conrad Hotels & Resorts, LXR Hotels & Resorts and Hilton Hotels & Resorts at the integrated Resorts World Las Vegas complex, Hilton is making an epic return to this top-tier travel destination, bringing new premium and luxury brands to the Strip. “Hilton helped create the Las Vegas we know today – the ente
Toshiba's Chairperson of the Board of Directors Issues Open Letter to Its Shareholders18.6.2021 11:06:00 CEST | Press release
Toshiba Corporation (TOKYO:6502) today announced that Osamu Nagayama, Chairperson of Toshiba’s Board of Directors, has issued an open letter to the company's shareholders. The full text of the letter is as follows: Dear Shareholders As the Chairperson of the Board of Directors of Toshiba Corporation ("Toshiba", the "Company"), I would like to express my deep regret regarding recent unacceptable events at the Company which have eroded your trust in us. You would have seen that we have already taken decisive and immediate action following the release of the Investigation Report, amending the slate of nominees for directors, committee members and executive officers ahead of the upcoming AGM on June 25. I, together with the Board, am fully committed to ensuring we improve your Company's governance fundamentally and enhance its corporate value. United, we shall be taking the following concrete steps with urgency: In order to stop recurrence, we will conduct an inquiry, with third party part