31IN - The role of molecular imaging in early drug development

Date 01 October 2012
Event ESMO Congress 2012
Session A paradigm shift in early drug development: Individualizing to more patient benefit
Topics Drug Development
Translational Research
Presenter Kristoff Muylle
Authors K. Muylle
  • Institut Jules Bordet, ULB, 1000 - Brussels/BE


Molecular cancer biology revealed an ever-increasing number of disease regulating intracellular and extracellular tumour targets. These new insights in the pathogenesis of tumor cells have lead to the development of a broad range of targeted therapeutic agents. In cancer, few targets have been identified that cover all types of cancer from a given site of origin. Hence, patient selection by molecular characterization of disease subtype in an individual patient becomes increasingly important in order to avoid unnecessary toxicity, improve patient outcome and reduce the costs for clinical trials. Biomarkers are objectively measured indicators of biological and pathogenic processes and can be used to predict patient outcome (regardless of therapy), to predict response to specific therapies and for response assessment (monitoring). The advantages of imaging biomarkers over those that require a biopsy sample include non-invasiveness, the ability to quantify cellular targets for the entire disease burden, and thereby to avoid the sampling error that can occur with heterogeneous receptor expression and the potential for serial studies of the in vivo effects of a drug on the target. In terms of drug development, predictive imaging biomarkers have a high potential for reducing costs of clinical trials, as they can be used for enriching patient selection by assessing drug targeting and/or early-on response prediction. The scope of this presentation is to highlight the potential of molecular imaging in drug development, illustrated by examples where molecular imaging has been implemented in clinical trials.


The author has declared no conflicts of interest.