Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof

A method of treating chronic infection in a human patient in need thereof comprising:

• administering to the human patient an effective amount of an anti-human PD-1 antibody formulation comprising:
• a) about 100 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof;
• b) about 5 mM to about 20 mM histidine buffer;
• c) about 6% to about 8% weight/volume (w/v) sucrose;
• d) about 0.01% to about 0.10% polysorbate 80;
• and
• e) about 1 mM to about 20 mM L-methionine, or a pharmaceutically acceptable salt thereof,
• wherein the anti-human PD-1 antibody or antigen binding fragment thereof comprises three light chain CDRs comprising CDRL1 of SEQ ID NO:1, CDRL2 of SEQ ID NO:2 and CDRL3 of SEQ ID NO:3 and three heavy chain CDRs of CDRH1 of SEQ ID NO:6, CDRH2 of SEQ ID NO:7 and CDRH3 of SEQ ID NO:8.

A method of treating cancer in a human patient in need thereof, the method comprising administering to the human patient an effective amount of an anti-human PD-1 antibody formulation comprising:

• a) about 100 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof;
• b) about 5 mM to about 20 mM histidine buffer;
• c) about 6% to about 8% weight/volume (w/v) sucrose;
• d) about 0.01% to about 0.10% polysorbate 80;
• and
• e) about 1 mM to about 20 mM L-methionine, or a pharmaceutically acceptable salt thereof,
• wherein the anti-human PD-1 antibody or antigen binding fragment thereof comprises three light chain CDRs comprising CDRL1 of SEQ ID NO:1, CDRL2 of SEQ ID NO:2 and CDRL3 of SEQ ID NO:3 and three heavy chain CDRs of CDRH1 of SEQ ID NO:6, CDRH2 of SEQ ID NO:7 and CDRH3 of SEQ ID NO:8.

A method of treating cancer in a human patient in need thereof, the method comprising administering to the human patient an effective amount of an anti-human PD-1 antibody formulation comprising:

• a) about 125 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof;
• b) about 10 mM histidine buffer,
• c) about 7% w/v sucrose,
• d) about 0.02% polysorbate 80,
• e) about 10 mM L-methionine, or a pharmaceutically acceptable salt thereof,
• f) a pH between 5.0 and 6.0,
• wherein the anti-human PD-1 antibody or antigen binding fragment thereof is pembrolizumab,
• wherein the formulation is administered by subcutaneous administration.