First european biomarker driven umbrella trial in recurrent / metastatic squamous cell carcinoma of the head & neck

L’Institut Roi Albert II des Cliniques Universitaires Saint-Luc (UCL) and OncoDNA to partner with EORTC for the first european biomarker driven umbrella trial in recurrent / metastatic squamous cell carcinoma of the head & neck

Recurrent/metastatic squamous cell carcinoma of the head and the neck has a dismal prognosis. This is a clear unmet medical need. Today, treatment of head and neck cancer is based on tumor location and disease staging and not on tumor biology. Precision medicine aims to propose a personalized treatment strategy according to the molecular alterations of the tumor. Molecular alterations that we are able to target with specific therapies have been recently characterized in head and neck cancer, offering new treatment opportunities.

The European Organisation for Research and Treatment of Cancer (EORTC) under the leadership of Prof. Jean-Pascal Machiels and Dr. Rachel Galot from the EORTC Head & Neck Cancer Group has initiated the first international, multicentre study utilizing a personalized biomarker-based treatment strategy and immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (H&N). This in partnership with the “Institut Roi Albert II” from Cliniques universitaires Saint-Luc, the “Institut de recherche expérimentale et Clinique (IREC) from University of Louvain, Belgium-based OncoDNA SA, The Cancer Theranostic Company, and the EORTC

Jean-François Laes, OncoDNA’s CTO, explained. « It’s about two years now that we have started to discuss with Prof. Machiels about the interest of putting together his world-renowned expertise in head and neck cancer and OncoDNA’s cancer precision medicine knowledge to study how to further improve metastatic head and neck cancer care.”

This collaboration led to the development of the first international, European-based umbrella biomarker-driven clinical trial for patients suffering from recurrent / metastatic H&N, EORTC 1559 HNCG: UPSTREAM study (NCT: NCT03088059). Patients will be allocated to standard of care, targeted therapies or immunotherapies trials based on a comprehensive molecular characterization of the patients’ cancer. This stratification will be performed by OncoDNA with a dedicated characterization solution combining Next Generation Sequencing and specific immunohistochemistry assays (IHC).

According to Prof. Jean-Pascal Machiels and Dr. Rachel Galot, working at the University of Louvain and Cliniques Universitaires Saint-Luc: “ Designing this trial has been a real challenge in terms of trial methodology but also logistically to convince all the partners to work together to finally come with one unique trial. We will personalize the treatment of each patient based on the molecular profile of their own tumor. This study is an important step to improve patient outcome”

This project would not have been possible without EORTC and its expertise in clinical research methodology and providing the needed network and infrastructure to advance science and new treatments through clinical trials, as well as for securing the partnership with the pharmaceutical industry sector for access to new anticancer agents. EORTC1559 study will be activated in 40 centers spread in 5 European countries. The study has already confirmed 5 study arms testing 3 varying targets and we hope to extend further, to offer maximum access to potential new drugs to patients suffering from this form of cancer. Denis Lacombe, EORTC’s Director General said: “This adds to the EORTC portfolio of studies addressing precision oncology. It confirms the leadership of our organization in capacity building and implementing innovative approaches across all types of cancer, leaving no one behind”.

The trial will be opened to patients recruitment in the coming months depending on regulatory clearance.

About Institut Roi Albert II- Cliniques universitaires Saint-Luc
An essential reference centre in Europe and a leader in French-speaking Belgium, the Cliniques Universitaires Saint-Luc King Albert II Institute treats all types of adult and childhood cancer. We fight against cancer while giving patients comprehensive and humane care. Our quest for excellence is in three main academic fields: clinical care, research and teaching.

About Institut de recherche expérimentale et Clinique (IREC) from University of Louvain
The Institute brings together different research groups who work to improve our understanding of disease mechanisms, as well as to discover and/or develop new therapeutic strategies. Research covers a wide range of biomedical problems within 21 research groups working in close collaboration with the Cliniques universitaires Saint-Luc, in Brussels, and Mont-Godinne, in Yvoir.
A part of this work is financed by the Fondation Louvain, the foundation of the University of Louvain.

About OncoDNA SA
Based in Belgium, OncoDNA is an affiliated company of IPG (Institute of Pathology and Genetics) and is a leading company specialized in the personalized analysis of tumor DNA. OncoDNA currently has two services, OncoDEEP and OncoTRACE, used for the targeted sequencing or complete sequencing of tumor genomes. These medical innovations assist medical doctors with treatment choice and/or provide better monitoring of tumor evolution in patients. For more information, please visit the OncoDNA website.

About EORTC
The European Organisation for the Research and Treatment of Cancer (EORTC) unites cancer clinical research experts to define better treatments for cancer patients to prolong survival and improve quality of life.

Both international and multidisciplinary, EORTC’s Network comprises over 4600 collaborators involved in cancer treatment and research in more than 800 hospitals across 35 countries.

Through translational and clinical research, EORTC offers an integrated approach to therapeutic strategies, drug evaluation programs, survivorship issues, and quality of life.
EORTC Headquarters, a unique international clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.

The EJC is the official journal of the EORTC.

For more information, contact:

http://www.eortc.org/clinical-trials-database/

Prof. Jean-Pascal Machiels and Dr. Rachel Galot
Service d’oncologie Médicale, Institut Roi Albert II, Cliniques universitaires Saint-Luc
Avenue Hippocrate 54/B1.54.07
1200 Woluwe-Saint-Lambert
Phone: +3227645457
https://uclouvain.be/fr/instituts-recherche/irec
http://www.institutroialbertdeux.be

Jean-Pol Detiffe
Chief Executive Officer
OncoDNA SA
1 Rue Louis Breguet
6041 Gosselies, Belgium
Phone: +32 71 183 500
www.oncodna.com

Dr. Denis Lacombe
Director General
EORTC AISBL / IVZW
Avenue Emmanuel Mounier 83/11
1200 Brussels
Belgium