Combination therapy of a type ii anti-cd20 antibody with a selective bcl-2 inhibitor

A method for the treatment of chronic lymphocytic leukemia in a human patient suffering from relapsed or refractory or previously untreated chronic lymphocytic leukemia, comprising

• co-administering to the patient a GA101 antibody and 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or a pharmaceutically acceptable salt thereof in multiple dosing cycles, followed by
• administering to the patient 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or a pharmaceutically acceptable salt thereof alone in the absence of the GA101 antibody for one or more dosing cycles;
• wherein;
• each dosing cycle is for at least 2, 3, 4, 5 or 6 weeks,
• 500 mg to 3000 mg of the GA101 antibody is administered once per dosing cycle for one or more dosing cycles of the multiple dosing cycles, and
• 10 mg to 1,000 mg of 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or a pharmaceutically acceptable salt thereof is administered each day per dosing cycle for one or more dosing cycles of the multiple dosing cycles when co-administered and the one or more dosing cycles when administered alone in the absence of the GA101 antibody.

A method for the treatment of diffuse large B-cell lymphoma in a human patient with diffuse large B-cell lymphoma comprising

• co-administering to the patient a GA101 antibody and 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or a pharmaceutically acceptable salt thereof in multiple dosing cycles, followed by
• administering to the patient 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or pharmaceutically acceptable salt thereof alone in the absence of said GA101 antibody for one or more dosing cycles;
• wherein:
• each dosing cycle is for at least 2, 3, 4, 5 or 6 weeks;
• 500 mg to 3000 mg of the GA101 antibody is administered once per dosing cycle for one or more dosing cycles of the multiple dosing cycles;
• and
• 10 mg to 1,000 mg of 2-(2H-pyrrolo[2,3-b]pyridin-4-yloxy)-4-((2-(4-chlorophenyl)-4,4-dimethyleyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-((tetrahydro-2H-pyran-4-yl)methylamino)phenylsulfonyl)benzamide or pharmaceutically acceptable salt thereof is administered each day per dosing cycle for one or more dosing cycles of the multiple dosing cycles and/or administered alone in the absence of said GA101 antibody each day per dosing cycle for at least one of the one or more dosing cycles.