Combination of anti tim-3 antibody mbg453 and anti tgf-beta antibody nis793, with or without decitabine or the anti pd-1 antibody spartalizumab, for treating myelofibrosis and myelodysplastic syndrome

A combination comprising a TIM-3 inhibitor and a TGF-β inhibitor for use in treating a myelodysplastic syndrome in a subject.

A method of treating a myelodysplastic syndrome (MDS) in a subject, comprising administering to the subject a combination of a TIM-3 inhibitor and a TGF-β inhibitor.

A method of treating a myelofibrosis in a subject, comprising administering to the subject a combination of a TIM-3 inhibitor and a TGF-β inhibitor.

A combination comprising MBG453 and NIS793 for use in treating a myelofibrosis in a subject,

• optionally wherein the combination further comprising decitabine;
• optionally wherein the combination further comprises PDR001, and optionally wherein MGB453 is administered at a dose of 600 mg once every three weeks, NIS793 is administered at a dose of 2100 mg once every three weeks, PDR001 is administered at a dose of 300 mg once every three weeks, and decitabine is administered at a dose of about 5 mg/m2 to about 20 mg/m2 on days 1, 2, and 3 of a 42 day cycle.

A method of treating myelofibrosis in a subject, comprising administering to the subject a combination of MBG453 and NIS793,

• optionally wherein the combination further comprises decitabine,
• optionally wherein the combination further comprises PDR001, and
• optionally wherein MGB453 is administered at a dose of 600 mg once every three weeks, NIS793 is administered at a dose of 2100 mg once every three weeks, PDR001 is administered at a dose of 300 mg once every three weeks, and decitabine is administered at a dose of about 5 mg/m2 to about 20 mg/m2 on days 1, 2, and 3 of a 42 day cycle.

A combination comprising MBG453 and NIS793 for use in treating a myelodysplastic syndrome (MDS) in a subject,

• optionally wherein MGB453 is administered at a dose of 600 mg once every three weeks, and NIS793 is administered at a dose of 2100 mg once every three weeks.

A combination comprising MBG453 and NIS793 for use in treating a myelodysplastic syndrome (MDS) in a subject,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, and NIS793 is administered at a dose of 2100 mg once every three weeks.

A method of treating myelodysplastic syndrome (MDS) in a subject, comprising administering to the subject a combination of MBG453 and NIS793,

• optionally wherein MGB453 is administered at a dose of 600 mg once every three weeks, and NIS793 is administered at a dose of 2100 mg once every three weeks.

A method of treating myelodysplastic syndrome (MDS) in a subject, comprising administering to the subject a combination of MBG453 and NIS793,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, and NIS793 is administered at a dose of 2100 mg once every three weeks.

A combination comprising MBG453, NIS793, and canakinumab, for use in treating a myelodysplastic syndrome (MDS) in a subject,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, NIS793 is administered at a dose of 2100 mg once every three weeks, and canakinumab is administered at a dose of 250 mg once every four weeks.

A method of treating myelodysplastic syndrome (MDS) in a subject, comprising administering to the subject a combination of MBG453, NIS793, canakinumab,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, NIS793 is administered at a dose of 2100 mg once every three weeks, and canakinumab is administered at a dose of 250 mg once every four weeks.

A combination comprising MBG453, NIS793, and canakinumab, for use in treating a myelodysplastic syndrome (MDS) in a subject,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, NIS793 is administered at a dose of 1400 mg once every three weeks, and canakinumab is administered at a dose of 250 mg once every four weeks.

A method of treating myelodysplastic syndrome (MDS) in a subject, comprising administering to the subject a combination of MBG453, NIS793, canakinumab,

• optionally wherein MGB453 is administered at a dose of 800 mg once every four weeks, NIS793 is administered at a dose of 1400 mg once every three weeks, and canakinumab is administered at a dose of 250 mg once every four weeks.