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.”