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

The LESS study will evaluate reduced endocrine therapy for HR+/HER2- patients with MammaPrint^® Ultra Low tumors to improve quality of life without compromising outcomes

Study strengthens Agendia’s growing global footprint in breast cancer to inform personalized treatment planning worldwide

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.

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