Cytokine profiling analysis

A method of treating a patient group in need of an anti-cancer treatment comprising administering to a patient within the patient group an effective amount of an anti-PD-1 antibody or antigen-binding portion thereof (“anti-PD-1 antibody”) or an effective amount of an anti-PD-L1 antibody or antigen-binding portion thereof (“anti-PD-L1 antibody”);

• wherein the patient has been identified as having a cytokine score that is higher than an average cytokine score;
• wherein the cytokine score is the sum of a point designated to the level of at least two cytokines in a sample obtained from the patient, wherein the point is 2 if the sample has a high concentration of a cytokine that is positively associated with overall survival of the patient following the administration of the anti-PD-1 antibody or the anti-PD-L1 antibody or a low concentration of a cytokine that is negatively associated with overall survival of the patient following the administration of the anti-PD-1 antibody or the anti-PD-L1 antibody, wherein the point is 0 if the sample has a low concentration of a cytokine that is positively associated with the overall survival of the patient following the administration of the anti-PD-1 antibody or the anti-PD-L1 antibody or a high concentration of a cytokine that is negatively associated with the overall survival of the patient following the administration of the anti-PD-1 antibody or the anti-PD-L1 antibody, and wherein the point is 1 if the sample has a medium concentration of a cytokine that is either negatively or positively associated with overall survival of the patient following the administration of the anti-PD-1 antibody or the anti-PD-L1 antibody;
• wherein the positively associated cytokines comprise one or more of MIG, IL-1RA, and MMP-3;
• wherein the negatively associated cytokines comprise one or more of IL-8, FRTN, ICAM, VWF, MICA, IP-10, CRP, IL-18, IL-6, and MIP1B;
• wherein a high cytokine score is determined by measuring the expression of the cytokine in a sample obtained from each patient of the patient group prior to administering the anti-PD-1 antibody or the anti-PD-L1 antibody and dividing the sum of the individual cytokine expressions by the number of patients to obtain a median, wherein an expression level that is at least 1% higher than the median is characterized as a high cytokine score;
• wherein an expression that is at least 1% lower than the median is characterized as a low cytokine score;
• and
• wherein the average cytokine score is determined by measuring a cytokine score from a sample obtained from each patient of the patient group prior to administering the anti-PD-1 antibody or the anti-PD-L1 antibody and dividing the sum of the individual cytokine scores by the number of patients.