Business Wire

CA-AGENDIA

16.11.2022 15:01:35 CET | Business Wire | Press release

Share
Agendia Announces First Patient Enrolled in Prospective LESS Clinical Study, Sponsored by Unicancer, to De-escalate Endocrine Therapy in Women with Early Breast Cancer

Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, today announced the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia. In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024.

“We are excited to identify early breast cancer tumors and further investigate the ability to reduce endocrine therapy duration, in an effort to minimize significant and varying side effects, while maintaining high survival rates,” said Fabrice André, MD, PhD, Professor in the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France and Co-coordinating Investigator of the study.

Elise Deluche, MD, Deputy Head of Department at Centre Hospitalier Universitaire de Limoges and Co-coordinating Investigator of the study, added, “Enabling personalized treatments to prevent over- and undertreatment in breast cancer care could give women freedom from intensive long-term treatment regimens that may not increase their chance of cure.”

Previous studies have shown patients with HR+/HER2- breast cancer with a MammaPrint Ultra Low result can have an excellent prognosis at 20 years with reduced endocrine therapy.

“The LESS study is an important addition to Agendia leading the field in uncovering robust insights for patients and their providers to tailor treatments unique to every tumor,” said William Audeh, MD, Chief Medical Officer at Agendia. “Through our partnership with Unicancer, we are expanding knowledge on the complexity of breast cancer and enabling further personalized treatments in cancer care.”

Agendia’s singular focus on breast cancer facilitates continued investment in global research to unravel the intricacies of precision medicine and drive personalized treatment planning for women with breast cancer. This study reinforces Agendia’s commitment to practice changing research that will aid decision-making, aimed at improving outcomes.

About Agendia

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

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. 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 potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

About Unicancer

Unicancer is the only French hospital network 100% dedicated to the fight against cancer and the only national hospital federation dedicated to cancer. It brings together the 18 French Cancer Comprehensive Centres (FCCCs), private not-profit health establishments, spread over 20 hospital sites in France, as well as 2 affiliated establishments. The FCCCs take care of nearly 540,000 patients per year (in short-stay, HAD and outpatient procedures). Unicancer is also the leading academic promoter of clinical trials in oncology, on a European scale, with 109 active clinical trials promoted, 20,000 patients included, 83,000 patients registered in the ESME database. Recognised as a leader in research in France, the Unicancer network enjoys a worldwide reputation with the production of one third of French publications of international importance in oncology (source: bibliometric study/Thomson Reuters). In total, more than 700 clinical trials (inclusions or follow-ups) are promoted in 2021 by the Unicancer network, more than 16% of CLCC patients are included in clinical trials and more than half of the PHRCs devolved to FCCCs.

The 18 FCCCs and the Unicancer R&D department are ISO 9001 certified.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20221116005249/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release

A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us

Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release

Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas

ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release

OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future

Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release

Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority

Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release

Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye