Combination therapy of an anti cd20 antibody with a btk inhibitor

Abstract

The present invention is directed to the combination therapy of an anti-CD20 antibody with a BTK inhibitor for the treatment of cancer, especially to the combination therapy of CD20 expressing cancers with a type I anti-CD20 antibody or an afucosylated humanized B-Ly1 antibody and a BTK inhibitor.

We claim: 
     
         1 . An anti-CD20 antibody for the treatment of cancer in combination with a BTK inhibitor. 
     
     
         2 . The antibody according to  claim 1 , wherein said anti-CD20 antibody is type I anti-CD20 antibody or an afucosylated anti-CD20 antibody with an amount of fucose of 60% or less of the total amount of oligosaccharides (sugars) at Asn297. 
     
     
         3 . The antibody according to  claim 1 , wherein said cancer is a CD20 expressing cancer. 
     
     
         4 . The antibody according to  claim 1 , wherein said CD20 expressing cancer is a lymphoma or lymphocytic leukemia. 
     
     
         5 . The antibody according to  claim 2 , wherein said afucosylated anti-CD20 antibody is a humanized B-Ly1 antibody. 
     
     
         6 . The antibody according to  claim 2 , wherein said afucosylated anti-CD20 antibody is obinutuzumab. 
     
     
         7 . The antibody according to  claim 1 , wherein said type I anti-CD20 antibody is rituximab. 
     
     
         8 . The antibody according to  claim 1 , wherein said BTK inhibitor is 6-amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one or a salt thereof. 
     
     
         9 . The antibody according to  claim 1 , further comprising one or more additional other cytotoxic, chemotherapeutic or anti-cancer agents, or compounds or ionizing radiation enhancing the effects of such agents are administered. 
     
     
         10 . A pharmaceutical composition comprising a combination of a type I anti-CD20 antibody or a humanized B-Ly1 antibody which afucosylated with an amount of fucose of 60% or less of the total amount of oligosaccharides (sugars) at Asn297, and a BTK inhibitor which is selected from the group consisting of 6-amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one or a salt thereof for the treatment of cancer. 
     
     
         11 . A method of treatment of patient suffering from cancer by administering a type I anti-CD20 antibody or an afucosylated anti-CD20 antibody with an amount of fucose of 60% or less of the total amount of oligosaccharides (sugars) at Asn297, in combination with a BTK inhibitor, to a patient in the need of such treatment. 
     
     
         12 . The method according to  claim 11 , wherein said cancer is a CD20 expressing cancer. 
     
     
         13 . The method according to  claim 11 , wherein said CD20 expressing cancer is a lymphoma or lymphocytic leukemia. 
     
     
         14 . The method according to  claim 11 , wherein said afucosylated anti-CD20 antibody is a humanized B-Ly1 antibody. 
     
     
         15 . The method according to  claim 11 , wherein said type I anti-CD20 antibody is rituximab. 
     
     
         16 . The method according to  claim 11 , wherein said BTK inhibitor is selected from the group consisting of 6-amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one or a salt thereof. 
     
     
         17 . The method according to  claim 11 , further comprising one or more additional other cytotoxic, chemotherapeutic or anti-cancer agents, or compounds or ionizing radiation enhancing the effects of such agents are administered.