WINTHER Trial design released

Posted: Thursday, June 28, 2012

Paris, June 28, 2012 - The WIN Consortium (Worldwide Innovative Networking in personalized cancer medicine), announces the launch of WINTHER, an original academic and international clinical trial. This is the first clinical trial offering a choice of therapy guided by the biology to the majority of patients included in the study. From a double biopsy of the tumor (or metastasis) and normal tissue of each patient, a complete biological analysis will be carried out (DNA, RNA and microRNA) with the most advanced technologies. The therapeutic decision will be discussed based on an estimated drug efficacy scoring bioinformatics tool based on these investigations. The European Community, under the EU FP7 program, has declared WINTHER eligible for a grant, which is currently under negotiation. This recognition by an independent European jury is a guarantee of the value of the scientific concept and methodology of the project. The aim of this study is to propose a personalized treatment to the vast majority of patients. This strategy represents a breakthrough compared to current oncology practice, which at best offers a personalized biology-guided therapy to 30 % of patients involved in clinical trials.

Professor Jean-Charles Soria, oncologist at the Gustave Roussy Institute, is the global coordinator of the WINTHER trial to be conducted in four institutions: MD Anderson Cancer Center (Houston, Texas, USA), Vall d'Hebron Hospital (Spain), The Chaim Sheba Medical Center (Israel) and the Gustave Roussy Institute (Villejuif, France).

Professor Soria says:

WINTHER Design

Currently, most cancers are diagnosed at a late stage, and for the vast majority of patients, the therapeutic choice is not guided by the biology (DNA, RNA, and microRNA investigations) but remains based on standard protocols. Personalized medicine’s studies are primarily based on DNA analysis and ultimately, the choice of therapy is guided by these investigations for only 30% of patients who harbor known tumor DNA aberrations, and for which targeted therapy is available.

In WINTHER study, for the 70% of patients without known oncogenic events of the tumor DNA, the choice of therapy will be guided by analyzes of RNA tumor and normal matched tissue. The results of DNA and RNA analysis will undergo a bioinformatics program capable of determining a predictive score of efficacy for different therapies. The only limit of this approach is the success of the biopsy procedure of the tumor and normal matched tissue.

This scoring system can estimate the response to existing treatments on the market (standard or targeted, expensive or not) for a given patient. This complex bioinformatics tool integrates all known data on biomarkers, molecular aberrations, targeted or non-targeted therapies, predictive algorithms of efficacy.

The trial WINTHER includes about 200 patients with all types of metastatic solid tumors resistant to the last line of treatment. It will be conducted within two years and will start early 2013. The limited number of patients and especially the short duration of the study should enable to obtain the first exploitable results in the short term.

The main objective of the study is to compare progression free survival with treatment guided by biology to progression free survival with the latest standard treatment prescribed in each of two parallel groups of test (arm 1: choice of treatment based on known abnormalities of tumor DNA, arm 2: choice of treatment based on DNA, RNA and miRNA of tumor and normal tissue investigations and bioinformatics prediction score).