Methods of treating chronic graft-versus-host disease using an anti-colony stimulating factor 1 receptor antibody

A method of treating chronic graft-versus-host disease (cGVHD) in a human subject in need thereof, the method comprising administering to the human subject a therapeutically effective amount of an antibody that binds to colony stimulating factor 1 receptor (CSF-1R), wherein the antibody comprises a variable heavy (VH) domain comprising VH complementarity determining region (CDR)1 (VH CDR1), VH CDR2, and VH CDR3,

• wherein:
• the VH CDR1 comprises the amino acid sequence GFSLTTYGMGVG (SEQ ID NO:6);
• the VH CDR2 comprises the amino acid sequence NIWWDDDKYYNPSLKN (SEQ ID NO:7);
• and
• the VH CDR3 comprises the amino acid sequence IGPIKYPTAPYRYFDF (SEQ ID NO:8);
• and
• wherein the antibody comprises a variable light (VL) domain comprising VL CDR1, VL CDR2, and VL CDR3, wherein:
• the VL CDR1 comprises the amino acid sequence LASEDIYDNLA (SEQ ID NO:9);
• the VL CDR2 comprises the amino acid sequence YASSLQD (SEQ ID NO:10);
• and
• the VL CDR3 comprises the amino acid sequence LQDSEYPWT (SEQ ID NO:11), and
• wherein:
• (i) the human subject is an adult patient or a pediatric patient with a body weight greater than about 55 kg and the antibody is administered intravenously once every two weeks at a dose of about 22 mg;
• (ii) the human subject is a pediatric patient with a body weight greater than or equal to about 30 kg and less than or equal to about 55 kg and the antibody is administered intravenously once every two weeks at a dose of about 14 mg;
• or
• (iii) the human subject is a pediatric patient with a body weight less than about 30 kg and the antibody is administered intravenously once every two weeks at a dose of about 9 mg.

A method of treating chronic graft-versus-host disease (cGVHD) in a human subject in need thereof, the method comprising administering to the human subject a therapeutically effective amount of an antibody that binds to colony stimulating factor 1 receptor (CSF-1R), wherein the antibody comprises a variable heavy (VH) domain comprising VH complementarity determining region (CDR)1 (VH CDR1), VH CDR2, and VH CDR3,

• wherein:
• the VH CDR1 comprises the amino acid sequence GFSLTTYGMGVG (SEQ ID NO:6);
• the VH CDR2 comprises the amino acid sequence NIWWDDDKYYNPSLKN (SEQ ID NO:7);
• and
• the VH CDR3 comprises the amino acid sequence IGPIKYPTAPYRYFDF (SEQ ID NO:8);
• and
• wherein the antibody comprises a variable light (VL) domain comprising VL CDR1, VL CDR2, and VL CDR3, wherein:
• the VL CDR1 comprises the amino acid sequence LASEDIYDNLA (SEQ ID NO:9);
• the VL CDR2 comprises the amino acid sequence YASSLQD (SEQ ID NO:10);
• and
• the VL CDR3 comprises the amino acid sequence LQDSEYPWT (SEQ ID NO:11), and
• wherein:
• (i) the human subject has a body weight greater than about 60 kg and the antibody is administered intravenously once every two weeks at a dose of about 23 mg;
• (ii) the human subject has a body weight greater than or equal to about 40 kg and less than or equal to about 60 kg and the antibody is administered intravenously once every two weeks at a dose of about 17 mg;
• or
• (iii) the human subject has a body weight less than about 40 kg and the antibody is administered intravenously once every two weeks at a dose of about 10.5 mg.

A method of treating chronic graft-versus-host disease (cGVHD) in a pediatric human subject in need thereof, the method comprising administering to the pediatric human subject a therapeutically effective amount of an antibody that binds to colony stimulating factor 1 receptor (CSF-1R), wherein the antibody comprises a variable heavy (VH) domain comprising VH complementarity determining region (CDR)1 (VH CDR1), VH CDR2, and VH CDR3,

• wherein:
• the VH CDR1 comprises the amino acid sequence GFSLTTYGMGVG (SEQ ID NO:6);
• the VH CDR2 comprises the amino acid sequence NIWWDDDKYYNPSLKN (SEQ ID NO:7);
• and
• the VH CDR3 comprises the amino acid sequence IGPIKYPTAPYRYFDF (SEQ ID NO:8);
• and
• wherein the antibody comprises a variable light (VL) domain comprising VL CDR1, VL CDR2, and VL CDR3, wherein:
• the VL CDR1 comprises the amino acid sequence LASEDIYDNLA (SEQ ID NO:9);
• the VL CDR2 comprises the amino acid sequence YASSLQD (SEQ ID NO:10);
• and
• the VL CDR3 comprises the amino acid sequence LQDSEYPWT (SEQ ID NO:11), and
• wherein the antibody is administered intravenously once every two weeks at a dose of 0.35 mg/kg body weight of the treated pediatric human subject.

A method of treating chronic graft-versus-host disease (cGVHD) in a population of human subjects in need thereof, the method comprising administering to each member of the population of human subjects a therapeutically effective amount of an antibody that binds to colony stimulating factor 1 receptor (CSF-1R), wherein the antibody comprises a variable heavy (VH) domain comprising VH complementarity determining region (CDR)1 (VH CDR1), VH CDR2, and VH CDR3,

• wherein:
• the VH CDR1 comprises the amino acid sequence GFSLTTYGMGVG (SEQ ID NO:6);
• the VH CDR2 comprises the amino acid sequence NIWWDDDKYYNPSLKN (SEQ ID NO:7);
• and
• the VH CDR3 comprises the amino acid sequence IGPIKYPTAPYRYFDF (SEQ ID NO:8);
• and
• wherein the antibody comprises a variable light (VL) domain comprising VL CDR1, VL CDR2, and VL CDR3, wherein:
• the VL CDR1 comprises the amino acid sequence LASEDIYDNLA (SEQ ID NO:9);
• the VL CDR2 comprises the amino acid sequence YASSLQD (SEQ ID NO:10);
• and
• the VL CDR3 comprises the amino acid sequence LQDSEYPWT (SEQ ID NO:11),
• wherein the antibody is administered intravenously once every two weeks at a dose of 0.3 mg/kg body weight of each treated human subject, and
• wherein the overall response rate in the population of human subjects within the first six months after initiation of treatment is at least 60%.