Patent ID: 8460886

Claim:
A method for evaluating the therapeutic efficacy of an anti-human PD-1 antibody in treating a cancer, comprising: (a) determining the pre-administration concentration(s) of one or more efficacy markers in the cancer patient's blood, wherein the one or more efficacy markers is/are selected from the group consisting of immunoglobulin(s), CD5 antigen-like protein, gelsolin, and fragments thereof; (b) administering an initial dose or doses of the anti-human PD-1 antibody to the cancer patient and determining the post-administration concentration(s) of said efficacy marker(s) in the patient's blood; (c) comparing the post-administration concentration(s) of said efficacy marker(s) with their pre-administration concentration(s); and (d) evaluating whether the anti-human PD-1 antibody is effective in treating the cancer, wherein at least a three-fold increase in the post-administration concentration(s) of the one or more efficacy markers compared to the pre-administration concentration(s) indicates that the anti-human PD-1 antibody is efficacious in treating the cancer.