Clinical Translation and Validation of a Predictive Biomarker for Patritumab an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody in Patients With Advanced Non-small Cell Lung Cancer

摘要

BackgroundDuring early clinical development, prospective identification of a predictive biomarker and validation of an assay method may not always be feasible. Dichotomizing a continuous biomarker measure to classify responders also leads to challenges. We present a case study of a prospective–retrospective approach for a continuous biomarker identified after patient enrollment but defined prospectively before the unblinding of data. An analysis of the strengths and weaknesses of this approach and the challenges encountered in its practical application are also provided.