Immune biomarkers encompass a wide range of blood-borne and cell-associated molecules whose detection or expression may change in response to an immune therapy. These immune therapies encompass a range of platforms including autologous cellular products, in other words, dendritic cells, prime boost DNA vaccines, chimeric antigen receptor (CAR) T cells and checkpoint inhibitors. The response to checkpoint inhibitors by a particular cancer may not be necessarily associated with a change in a particular immune biomarker; other immune biomarkers are needed to assess their association with treatment response or a change in the biology that can impact on the immunologic milieu. How these potential biomarkers can be incorporated into clinical trial design, and their role in interrogating the immunologic milieu will be discussed.
Keywords: CTLA-4; ICOS; PD-1; PD-L1; VISTA; biomarkers; bladder cancer; clinical trials; immune checkpoints; kidney cancer; neoadjuvant; prostate cancer; vaccines.