Quantitative Immunohistochemistry for Development of Predictive Biomarkers in Oncology Clinical Trials
In oncology studies, biomarkers have been effectively used to measure tumor progression and to evaluate efficacy of therapies. Increasingly they have been utilized to stratify different patient groups and to develop personalized therapeutic strategies. Towards this goal, immunohistochemistry (IHC) has been playing an increasing role to help understand the mechanism of action by measuring molecular targets for particular cancer types. Through quantitative analysis of IHC images, effective biomarkers can be predictors of disease prognosis and immune response of various immunotherapies.
Merck has developed and validated various IHC assays and quantitative analysis strategies for identifying and measuring presence of molecular targets for various cancer types using the Definiens platform. They have evaluated the specificity, sensitivity and reproducibility of the IHC assays and demonstrated that these can be used to support oncology clinical trials reliably to evaluate patient response. Development of such patient selection biomarkers is expected to accelerate enrollment and increase response rates, leading to more effective clinical trial designs.