Combination comprising a tim-3 inhibitor and a hypomethylating agent for use in treating myelodysplastic syndrome or chronic myelomonocytic leukemia

A method of treating a myelodysplastic syndrome (MDS) or a chronic myelomonocytic leukemia (CMML), in a subject, comprising administering to the subject a combination of a TIM-3 inhibitor and hypomethylating agent.

A combination comprising MBG453 and azacitidine for use in treating a CMML-2 in a subject.

A combination comprising MBG453 and azacitidine for use in treating an intermediate MDS, high risk MDS, or very high risk MDS in a subject.

A method of treating a CMML-2 in a subject, comprising administering to the subject a combination of MBG453 and azacitidine.

A method of treating an intermediate MDS, high risk MDS, or very high risk MDS in a subject, comprising administering to the subject a combination of MBG453 and azacitidine.

A method of treating a CMML-2 in a subject, comprising administering to the subject a combination of MBG453 and azacitidine, wherein:

• a) MBG453 is administered at a dose of about 800 mg once every four weeks on day 8 of a 28-day dosing cycle;
• and
• b) azacitidine is administered at a dose of about 75 mg/m2 a day for (i) seven consecutive days on days 1-7 of a 28-day dosing cycle, or (ii) five consecutive days on days 1-5, followed by a two-day break, then two consecutive days on days 8-9, of a 28-day cycle.

A combination comprising MBG453 and azacitidine for use in treating a CMML-2 in a subject, wherein:

• a) MBG453 is administered at a dose of about 800 mg once every four weeks on day 8 of a 28-day dosing cycle;
• and
• b) azacitidine is administered at a dose of about 75 mg/m2 a day for (i) seven consecutive days on days 1-7 of a 28-day dosing cycle, or (ii) five consecutive days on days 1-5, followed by a two-day break, then two consecutive days on days 8-9, of a 28-day cycle.

A method of treating an intermediate MDS, a high risk MDS, or a very high risk MDS in a subject, comprising administering to the subject a combination of MBG453 and azacitidine, wherein:

• a) MBG453 is administered at a dose of about 800 mg once every four weeks on day 8 of a 28-day dosing cycle;
• and
• b) azacitidine is administered at a dose of about 75 mg/m2 a day for (i) seven consecutive days on days 1-7 of a 28-day dosing cycle, or (ii) five consecutive days on days 1-5, followed by a two-day break, then two consecutive days on days 8-9, of a 28-day cycle.

A combination comprising MBG453 and azacitidine for use in treating an intermediate MDS, a high risk MDS, or a very high risk MDS in a subject, wherein:

• a) MBG453 is administered at a dose of about 800 mg once every four weeks on day 8 of a 28-day dosing cycle;
• and
• b) azacitidine is administered at a dose of about 75 mg/m2 a day for (i) seven consecutive days on days 1-7 of a 28-day dosing cycle, or (ii) five consecutive days on days 1-5, followed by a two-day break, then two consecutive days on days 8-9, of a 28-day cycle.