SP 3

Translation and clinical validation of biomarkers predicted by SYSACT

Recent preclinical and clinical studies suggest that combination therapy with targeted drugs or/and immunotherapeutic agents enhances therapeutic response and prolongs survival for patients with metastatic melanoma. Due to the large number of potential combinations it is not possible to conduct systematic clinical trials. The aim of this joint project is to pool the efforts of partners in the fields of systems biology, basic and clinical research and industry in the endeavour to identify and validate clinically salient predictive biomarkers and assays of clinical response. The common objective is to protect patients from ineffective, stressful treatments and avoid the use of therapies that are uneconomical due to lack of efficacy.
The objective of Sub-Section B of the project is to examine the clinical relevance of the systems biological models generated, verify the predictive validity of the biomarkers for therapeutic response and evaluate their functional relevance. To this end clinical data, tumour tissue, histological and immunohistochemical techniques and tumour cell lines are to be made available and functional assays carried out. The potential benefits of successful identification of clinically useful predictive biomarkers of therapeutic response are broad: such bio¬markers can protect patients from ineffective and stressful treatments and provide a basis for consultancy for partners in industry and their research with a view to optimizing the use of approved drugs and developing innovative substances and combination strategies.