Immunotherapeutic dosing regimens comprising pomalidomide and an anti-cs1 antibody for treating cancer

Abstract

The invention described herein relates to therapeutic dosing regimens and combinations thereof for use in enhancing the therapeutic efficacy of anti-CS1 antibodies in combination with one or more immunotherapeutic agents.

1 . A method for treating a patient with cancer comprising the administration of a combination therapeutic regiment comprising: (i) a therapeutically effective amount of pomalidomide; and (ii) a therapeutically effective amount of an anti-CS1 antibody, wherein said combination results in the synergistic reduction in tumor burden, tumor regression, tumor development, reduction in M-protein levels, plasma cells, and/or regression of said cancer. 
     
     
         2 . The method of  claim 1 , wherein said cancer is selected from the group consisting of: myeloma, multiple myeloma, relapsed multiple myeloma, refractory multiple myeloma, and smoldering multiple myeloma. 
     
     
         3 . The method of  claim 1 , wherein said anti-CS1 antibody is Elotuzumab. 
     
     
         4 . The method of  claim 1 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg, and said anti-CS1 antibody is administered at a dosage of about 10 mg/kg. 
     
     
         5 . The method of  claim 1 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg daily for 21 days, and said anti-CS1 antibody is administered at a dosage of about 10 mg/kg once every three weeks. 
     
     
         6 . A method for treating a patient with cancer comprising the administration of a combination therapeutic regiment comprising: (i) a therapeutically effective amount of pomalidomide; (ii) a therapeutically effective amount of an anti-CS1 antibody, and (iii) a therapeutically acceptable amount of dexamethasone, wherein said combination results in the synergistic reduction in tumor burden, tumor regression, tumor development, reduction in M-protein levels, plasma cells, and/or regression of said cancer. 
     
     
         7 . The method of  claim 6 , wherein said cancer is selected from the group consisting of: myeloma, multiple myeloma, relapsed multiple myeloma, refractory multiple myeloma, and smoldering multiple myeloma. 
     
     
         8 . The method of  claim 6 , wherein said anti-CS1 antibody is Elotuzumab. 
     
     
         9 . The method of  claim 6 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg, or via IV at a dose of about 8 mg. 
     
     
         10 . The method of  claim 6 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg daily for 21 days, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg once every three weeks, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg daily for 21 days, or via IV at a dose of about 8 mg weekly. 
     
     
         11 . A method for treating a multiple myeloma patient that has progressed after receiving an initial treatment, comprising the administration of a combination therapeutic regiment in which each component of said combination is separately administered, comprising: (i) a therapeutically effective amount of pomalidomide; (ii) a therapeutically effective amount of an anti-CS1 antibody, and (iii) a therapeutically acceptable amount of dexamethasone, wherein said combination stops said progression and effectively treats said patients multiple myeloma. 
     
     
         12 . A method for treating a multiple myeloma patient that is resistant to lenalidomide, comprising the administration of a combination therapeutic regiment in which each component of said combination is separately administered, comprising: (i) a therapeutically effective amount of pomalidomide; (ii) a therapeutically effective amount of an anti-CS1 antibody, and (iii) a therapeutically acceptable amount of dexamethasone, wherein said combination overcomes said patients lenalidomide resistance and effectively treats said patients multiple myeloma. 
     
     
         13 . The method of  claim 11 , wherein said anti-CS1 antibody is Elotuzumab. 
     
     
         14 . The method of  claim 13 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg, or via IV at a dose of about 8 mg. 
     
     
         15 . The method of  claim 13 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg daily for 21 days, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg once every three weeks, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg daily for 21 days, or via IV at a dose of about 8 mg weekly. 
     
     
         16 . A method for treating a multiple myeloma patient comprising the administration of a combination therapeutic regiment in which each component of said combination is separately administered, comprising: (i) a therapeutically effective amount of pomalidomide; (ii) a therapeutically effective amount of Elotuzumab, and (iii) a therapeutically acceptable amount of dexamethasone, wherein said combination effectively treats said patients multiple myeloma. 
     
     
         17 . The method of  claim 16 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg, or via IV at a dose of about 8 mg. 
     
     
         18 . The method of  claim 16 , wherein said immunomodulatory agent is administered at a dosage of about 4 mg daily for 21 days, said anti-CS1 antibody is administered at a dosage of about 10 mg/kg once every three weeks, and dexamethasone is administered either orally at a dose of about 28 mg to 40 mg daily for 21 days, or via IV at a dose of about 8 mg weekly in an overall 28 day dosing cycle, and optionally wherein said anti-CS1 antibody is administered at a dose of about 20 mg/kg in subsequent dosing cycles other than the first cycle.