According to the World Health Organization (WHO), a biomarker is defined as “any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease.”1There has been an increasing amount of research focusing on biomarkers in numerous therapeutic areas, especially oncology. Within oncology, a biomarker could be utilized to determine which patients may respond the best to a new or old medication, based both on safety and efficacy.
An example of where biomarkers may help to select the best medication for a patient and also assist in drug development is the tyrosine kinase inhibitor (TKI) dovitinib for renal cell carcinoma (RCC). Dovitnib was developed as an oral TKI that targeted multiple signaling pathways within the progression of RCC. In animal models, dovitinib showed significant tumor reduction by inhibiting the platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor (VEGFR), and fibroblast growth factor receptor (FGFR).2,3
In a large phase 3 trial, dovitinib was compared to another oral TKI, sorafenib, in patients with metastatic RCC.4 Patients in the dovitinib group had similar rates of progression-free survival (PFS) when compared with patients receiving sorafenib. In addition, the adverse events were similar between the two groups. Therefore, the authors concluded that although dovitinib did show activity in patients with metastatic RCC, it was no better than sorafenib. Similarly, a phase 2 study evaluating dovitinib versus sorafenib in patients with hepatocellular carcinoma (HCC) found similar overall survival (OS) and time to tumor progression (TTP).5
Based on these underwhelming results, the further development of dovitinib was slowed until recently. Oncology Venture is a company that will be in-licensing dovitinib from its parent company Novartis in hopes of using its specialized biomarker technology to help tailor its use in the correct patient population. This technology is called Drug Response Prediction (DRP™) and analyzes the genetic makeup of a specific cancer within a patient in hopes of finding an optimal treatment.6