EORTC, BIG, and Agendia Announce Completion of Patient Recruitment for International MINDACT Study

BRUSSELS, IRVINE, California, and AMSTERDAM, October 18, 2011 -

The EORTC, BIG, and Agendia, a commercial-stage molecular cancer diagnostics company, today announced the completion of patient registration for the EORTC 10041/BIG3-04 MINDACT (Microarray In Node negative and 1-3 positive lymph node Disease may Avoid Chemotherapy Trial) study. More than 6,600 patients in 111 institutions across nine countries were enrolled from February 2007 to July 2011 in this trial.

Genomic risk profiling lies at the heart of personalized management of cancer.  MINDACT is investigating the added clinical value of Mammaprint^TM to standard clinicopathological criteria for the accurate selection of breast cancer patients for adjuvant chemotherapy. The study aims to provide further evidence that early breast cancer patients with a low recurrence risk genomic profile by Mammaprint® may not need chemotherapy.  This would spare patients from burdensome side effects without increasing the risk of metastasis or reducing survival. The study is also designed to show whether MammaPrint^® can predict patient response to specific therapies.

Commercialized by Agendia, MammaPrint^® has been cleared by the FDA as a prognostic tool identifying patients at low risk of metastasis, and can already be used across the spectrum of breast cancer cases for this purpose (including ER positive and negative, and lymph node negative and positive). It is being tested in MINDACT to provide large-scale prospective validation of its clinical utility.

“The completion of patient recruitment is a major milestone for this groundbreaking trial. If MammaPrint^® is ultimately shown to predict individual patient response to the trial specific cancer therapies currently on the market, it will likely create significant and valuable synergies for the manufacturers of these drugs by improving treatment success rates,” said Bernhard Sixt, CEO and co-founder of Agendia. “In addition, MINDACT will likely generate new specific companion diagnostics that can be added to MammaPrint^® in Agendia’s Symphony™ decision support system to further improve its clinical value.”

According to the MINDACT principal investigators (Drs Emiel Rutgers, Martine Piccart, and Fatima Cardoso), “The enthusiasm and commitment of all the many people involved in MINDACT - surgeons, pathologists, medical oncologists, research nurses and patients - have proven the doubters wrong.  We are delighted to be able to show that it is possible to conduct such a complex international trial in a short period of time, and are convinced that MINDACT, with its rich collection of biological and clinical data, will nurture breast cancer research for years to come.”  

MINDACT is the largest European randomized prospective trial evaluating the clinical value of a genomic profile for risk assessment and adjuvant chemotherapy prescription for breast cancer. The trial’s complex logistics, including real-time collection of frozen tumor tissue, were proven feasible in a multinational, multicenter setting. Based upon patients’ risk of recurrence classification by MammaPrint® and clinicopathological criteria, they are offered adjuvant chemotherapy (a non-mandatory randomisation between commonly administered anthracycline-based regimens and the study combination of docetaxel plus capecitabine). Endocrine treatment is also offered to the patients whose tumors express hormone receptors (a non-mandatory randomisation between letrozole and tamoxifen followed by letrozole). The entire genomic profile of each patient’s tumor is also being analyzed, and this could allow research groups involved in the consortium to find new, specific companion diagnostics for the drugs administered in the trial. Agendia holds exclusive commercial rights to new RNA-based companion diagnostics that result from the trial but research using biological samples / clinical data is open to the entire scientific community.

About MINDACT

Coordinated by the European Organisation for Research and Treatment of Cancer (EORTC) and run under the BIG/TRANSBIG networks, MINDACT aims to provide confirmatory evidence that patients with a low recurrence risk signature by Mammaprint® may be spared chemotherapy and its burdensome side effects, without negative repercussions on survival rate. MINDACT, which involved sites in the Netherlands, France, Germany, Belgium, Spain, Italy, UK, Slovenia, and Switzerland, began recruiting patients in 2007 and its first results are expected in approximately three years.

Ancillary research is led by TRANSBIG, a consortium launched by BIG (Breast International Group) in 2004 and supported by the European Union’s 6^th Framework Program to promote international collaboration in translational research. Further research grants have been received from the Breast Cancer Research Foundation, Novartis, F. Hoffman La Roche, Sanofi-Aventis, the National Cancer Institute (NCI), the EBCC-Breast Cancer Working Group, the Jacqueline Seroussi Memorial Foundation, Prix Mois du Cancer du Sein, Susan G. Komen for the Cure, Fondation Belge Contre le Cancer, Dutch Cancer Society (KWF), Association Le Cancer du Sein, Parlons-en!, Deutsche Krebshilfe and the Grant Simpson Trust and Cancer Research UK. Whole genome analysis is provided in kind by Agendia.

This trial would not have been possible without such support and the collaboration of hundreds of healthcare professionals across multiple disciplines, and above all without the trust and participation of all the patients.

For more information on MINDACT please visit:

www.breastinternationalgroup.org/Publications/MINDACTBrochure.aspx 

About the EORTC

Founded in 1962, the EORTC is a nonprofit international cancer research organization under Belgian law. The EORTC has the mission to develop, conduct, coordinate and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patient quality of life. The EORTC is both multinational and multidisciplinary, and the EORTC Network comprises over 300 hospitals and cancer centers in over 30 countries which include some 2,500 collaborators from all disciplines involved in cancer treatment and research. 

For more information about the EORTC please visit: www.eortc.be

About the BIG

BIG is a non-profit organization for academic breast cancer research groups from around the world, headquartered in Brussels, Belgium. Founded in 1999, BIG comprises 50 groups based in Europe, Canada, Latin America, Asia and Australasia, representing several thousand specialized hospitals and research centers. BIG also works closely with the US National Cancer Institute and the North American Breast Cancer Groups. To make significant scientific advances in breast cancer research, reduce unnecessary duplication of effort, and optimally serve patients, large-scale collaboration is crucial. Therefore BIG facilitates breast cancer research by stimulating cooperation between its members and other academic networks, and partnering with, but working independently from, the pharmaceutical industry.

For more information about BIG please visit: www.breastinternationalgroup.org

About Agendia:

Agendia is a leading global commercial molecular diagnostic company that develops and markets genomic-based diagnostic products that improve the quality of life for cancer patients and simplifies complex treatment decisions for their physicians. Agendia’s Symphony™ suite of breast cancer products is based on the analysis of hundreds of genes in a patient’s breast and provides unprecedented biological insight to address complex treatment decisions. Symphony™ includes MammaPrint®, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint®, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, a therapy selection assay. Together, these tests help physicians determine a patient’s individual risk for metastasis, which patients will benefit from chemo or hormonal therapy, and which patients do not require these treatments and can instead be treated with other less arduous and costly methods.

In addition to the Symphony™ suite of tests, Agendia has a rich pipeline of genomic products in development based on its world-class genomic platform. The company also collaborates with pharmaceutical companies to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

Agendia was founded in 2003 as a spin-off of the Netherlands Cancer Institute and is based in Amsterdam, the Netherlands, and Irvine, California, United States.

For more information about Agendia please visit:  www.agendia.com.

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