The primary endpoint of the study is the objective tumor response or lack of early disease progression. The trial is expected to enroll approximately 30 patients at a dose of 50mcg/kg. Endogenous interleukin 21 (IL-21) has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play important roles in eliminating malignant and infected cells.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “There’s a great need for effective treatments for advanced stage melanoma. Our Phase I data suggests that IL-21 could be effective in treating metastatic melanoma. In this Phase II study, we’ll investigate IL-21 treatment further by administering the maximum dose that can be tolerated in the outpatient setting.”