Business Wire

Agendia’s MammaPrint ® Test is the First to Demonstrate the Ability to Predict Benefit from Extended Endocrine Treatment in NSABP B-42 Trial

Share

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced positive results from an analysis using its 70-gene MammaPrint® assay on samples from the NSABP B-42 trial. These results were reported as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

The abstract, titled “Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy (ELT) in the NRG Oncology/NSABP B-42 trial” and presented by Dr. Priya Rastogi of the NSABP, detailed a retrospective evaluation of 1,866 samples, almost half of the original trial’s tissue samples, which were representative of the entire cohort. The data showed that genomic testing with MammaPrint could identify a subset of patients in the NSABP B-42 cohort who were most likely to benefit from ELT. Patients with a MammaPrint Low Risk profile had significantly better rates of distant recurrence (DR), disease-free survival (DFS) and breast cancer free interval (BCFI) when treated with extended endocrine therapy. Conversely, genomically High Risk patients did not see this same benefit and likely could have been spared extended endocrine therapy.

Patients with a genomic Low Risk result were stratified into Ultra Low Risk and Low Risk groups. The benefit of extended endocrine therapy was primarily observed in the Low Risk (non-Ultra Low) group. The benefit of extended endocrine therapy in these MammaPrint Low Risk patients ranged from a 4.0% improvement in DR rate to a 9.5% increase in DFS. MammaPrint was the only test that predicted a 52% relative benefit reduction in BCFI events (7.9% absolute benefit) and a 36% relative benefit reduction in DFS events (9.5% absolute benefit) with ELT. Another genomic test, the BCI-H/I ratio, evaluated samples from the NSABP B-42 trial and did not confirm the predictive value of BCI for the efficacy of extended endocrine therapy; further study is needed to evaluate the test’s predictive ability.

“By stratifying patients beyond High or Low Risk, we are able to see a larger breadth of difference in genomic signatures,” said Adam Brufsky, MD, PhD, Co-Director of the Women’s Cancer Center at Magee Women’s Hospital of UPMC Hillman Cancer Center. “More granular information such as this allows us to better understand the biology of a tumor, and gets us closer to ensuring that each patient receives the data she needs to have informed discussions with her physician to decide on the best treatment path, even years after her initial treatment.”

The original NSABP B-42 trial, designed to determine whether ELT improves DFS after a standard 5 years of aromatase inhibitor-based therapy, enrolled nearly 4,000 postmenopausal women with stage I-IIIA hormone receptor-positive breast cancer, who were disease-free after about 5 years of treatment with an aromatase inhibitor or tamoxifen followed by an aromatase inhibitor. The trial arms were randomly assigned to either receive 5 years of letrozole – an endocrine therapy used commonly in adjuvant settings – or a placebo. The trial showed a numerical DFS benefit of 3.3% at 10 years from ELT for the entire study cohort; however, no clinical features that indicated which women would achieve this benefit were identified in the trial. This led to the search for genomic biomarkers which could predict the benefit of ELT, and was the basis for this translational study.

“We are pleased to have contributed to the NSABP B-42 trial findings, with the important observation that genomic profiling with MammaPrint identifies the cohort most likely to benefit from ELT, and those who are unlikely to benefit,” said William Audeh, MD, Chief Medical Officer at Agendia. “These data will be of value to clinicians, and women with breast cancer, as they make the challenging decision as to whether to undertake an additional five years of endocrine therapy, a decision for which clinical features offered little guidance.”

At ASCO 2021, Agendia also presented additional data about the Ultra Low Risk threshold from the MINDACT study as well as a larger suite of data from the company’s groundbreaking FLEX registry, a large-scale, prospective, observational breast cancer study using whole transcriptome sequencing. FLEX enables true precision oncology by recruiting patients from various ethnicities, ages and genders representative of the total breast cancer population as part of an ongoing effort to increase representation of diverse populations and data in clinical trials.

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media

Terri Clevenger
Westwicke/ICR Healthcare PR
Tel: 203.856.4326
Terri.Clevenger@icrinc.com

About Business Wire

Business Wire
Business Wire



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

ČSOB Insurance Selects Earnix to Implement Personalized Consumer P roducts and Rates15.6.2021 11:00:00 CEST | Press release

Earnix, a global provider of advanced rating, pricing, and product personalization solutions for insurers and banks, has been selected by one of the largest banking and insurance institutions in the Czech Republic, ČSOB Group, to integrate Earnix’s analytical personalization system into its personal lines insurance offering. Driven by cutting-edge analytics, artificial intelligence (AI) and machine learning (ML), Earnix’s “Personalize-It” solution determines and delivers the optimum product bundle(s) for insurance customers, thereby making the purchasing experience highly personalized and increasing consumer satisfaction while improving conversion and retention rates. “With our solution, ČSOB Insurance can take personalization to a higher level while meeting business objectives and maintaining a competitive advantage in the market,” said Udi Ziv, CEO at Earnix. “At a time when consumers are provided with dozens of insurance options, we empower insurers to position themselves as the bes

Samsung Brings Flagship Features to Broader Smartphone Market with LPDDR5 Multichip Package15.6.2021 10:00:00 CEST | Press release

Samsung Electronics Co., Ltd., the world leader in advanced memory technology, today announced that it has begun mass producing its latest smartphone memory solution, the LPDDR5 UFS-based multichip package (uMCP). Samsung’s uMCP integrates the fastest LPDDR5 DRAM with the latest UFS 3.1 NAND flash, delivering flagship-level performance to a much broader range of smartphone users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005507/en/ Samsung's uMCP with industry’s highest performance, capacity and efficiency for 5G applications (Photo: Business Wire) “Samsung’s new LPDDR5 uMCP is built upon our rich legacy of memory advancements and packaging know-how, enabling consumers to enjoy uninterrupted streaming, gaming and mixed reality experiences even in lower-tier devices,” said Young-soo Sohn, vice president of the Memory Product Planning Team at Samsung Electronics. “As 5G-compatible devices become more mainstream, we

Startups from 21 Countries Showcase Deep Tech Innovations at #InnoVEXVirtual15.6.2021 09:23:00 CEST | Press release

Startups are the key to technology development, and they are the driver for industry transformations and evolutions. In COMPUTEX 2021 Virtual, the event organizer, TAITRA, has dedicated a special hall for #InnoVEXVirtual. With 81 startups from 21 countries, TAITRA aims to empower these startups by bridging the network and business opportunities with them and the global technology ecosystem through the digital platform. Sparking creativity with global disruptors Since its first establishment in 2016, InnoVEX, the exhibit dedicated to startups at COMPUTEX, has successively hosted National Pavilions from France, Korea and the Netherland. The National Pavilions have become one of the exhibition highlights to the visitors, venture capitalists and media. This year, La French Tech Pavilion, organized by Business France, gathers 5 teams to showcase tech strength and diversity from France in the fields including Quantum Computing as a Service, Organic Photovoltaic, Wireless Charging, Processing

MACIF’s Successful Euro 1,75 bn Issuance Attracted Huge Appetite From European Investors15.6.2021 09:05:00 CEST | Press release

MACIF, Aéma Groupe’s affiliate, announces the successful issuance of a multi-tranche €1.75bn subordinated debt issuance comprising: - a €400mn Perpetual Non-Call 2029 Restricted Tier 1 fixed resettable rate notes bearing interest at an initial fixed rate of 3.50% until the first call date and expected to be rated Ba1 by Moody’s - a €850mn 2052 Non-Call 2032 Tier 2 fixed to floating rate notes bearing interest at an initial fixed rate of 2.125% until the first call date and expected to be rated Baa1 by Moody’s - a €500mn 2027 Tier 3 notes bearing interest at a 0.625% fixed rate coupon and expected to be rated Baa1 by Moody’s MACIF has met with over 85 institutional investors over phone calls which took place from 8th to 11th June 2021 in order to present the Group’s credit. With more than 400 investors participating into the multi-tranche transaction for a total book size over €12.1bn, this represents the first Euro triple-tranche subordinated from a European insurer. The three days of

Aragen Announce Multi-Year Partnership With FMC Corporation, Aims at Accelerating Agro-Chemical Pipeline15.6.2021 09:03:00 CEST | Press release

Aragen Life Sciences (formerly, GVK BIO), a leading Contract Research and Development Organization (CRDO), head quartered out of Hyderabad, India, announced a strategic partnership with FMC Corporation, a global leader in innovative agricultural science, that provides solutions towards crop protection, plant health, and professional pest and turf management. Through this collaboration, Aragen will support FMC’s global discovery and development needs, including discovery chemistry, discovery biology, and chemical process development. This partnership is focused on accelerating FMC Corporation’s agro-chemical pipeline. “It has been our privilege to have been able to assist FMC, one of the global leaders in crop science, accelerate its R&D, through this long term partnership. The expansion of this collaboration through all facets of discovery and development is a testimony to the trust and confidence that FMC has in Aragen - we look forward to driving several more success stories for our

KeyBank Goes Live With SmartStream’s Cloud Collateral Management Solution15.6.2021 09:00:00 CEST | Press release

SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announces KeyBank N.A. goes live with its TLM Collateral Management (formerly Algorithmics/IBM Collateral) OnDemand solution - offering coverage for cleared and non-cleared, over the-counter (OTC) derivatives, repo and securities lending margining. KeyBank needed to streamline its back-office workflow with a cloud offering that would enhance efficiencies within their collateral management operations - this included all data capture, validation, calculation and processing. In addition, the use of APIs links the application to various other reporting solutions and downstream systems. A powerful user interface provides clear and logical paths for the user, and a management dashboard will help with trend analysis and decision-making. Paula Janofsky, Swap Operations Director, KeyBank, states: “Moving to the cloud enabled us to further improve and automate our operational and credit risk

Polymateria Awarded as Technology Pioneer by World Economic Forum15.6.2021 09:00:00 CEST | Press release

Polymateria, the London-based British tech company that last year produced the world’s first fully recyclable and biodegradable plastic, was selected among hundreds of candidates as one of the World Economic Forum’s “Technology Pioneers”. Polymateria came through Imperial College London’s incubator system and counts a diverse portfolio of customers and partners from Indorama Ventures, to Hollywood Actress Robin Wright, purposeful auto racing Extreme E, Rolling Loud Festivals, DAZN Sports TV network and the Indian Government. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005173/en/ The World Economic Forum’s Technology Pioneers are early to growth-stage companies from around the world that are involved in the use of new technologies and innovation that are poised to have a significant impact on business and society. With their selection as Technology Pioneer, CEO Niall Dunne of Polymateria will be invited to participat

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom