Anti-pdl1 antibody formulations

Abstract

The invention provides stable aqueous pharmaceutical formulations comprising an anti-PDL1 antibody. The invention also provides methods for making such formulations and methods of using such formulations.

1 - 39 . (canceled) 
     
     
         40 : A method of treating cancer in a subject comprising administering an effective amount of a stable aqueous pharmaceutical formulation comprising an anti-programmed death ligand 1 (anti-PD-L1) monoclonal antibody in a concentration of 60 mg/ml, histidine acetate in a concentration of 20 mM, sucrose in a concentration of 120 mM, polysorbate 20 in a concentration of 0.04% (w/v), and pH 5.8; wherein said monoclonal antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:7, and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:32. 
     
     
         41 . (canceled) 
     
     
         42 : The method of  claim 40 , wherein the medicament is which is for intravenous (IV) administration. 
     
     
         43 : The method of  claim 40 , wherein the cancer is locally advanced or metastatic. 
     
     
         44 : The method of  claim 40 , wherein the cancer is selected from the group consisting of a solid tumor, a hematologic cancer, bladder cancer, brain cancer, breast cancer, colon cancer, colorectal cancer, gastric cancer, glioma, head cancer, leukemia, liver cancer, lung cancer, lymphoma, myeloma, neck cancer, ovarian cancer, melanoma, pancreatic cancer, renal cancer, salivary cancer, stomach cancer, thymic epithelial cancer, thyroid cancer, and squamous cell carcinoma of the head and neck. 
     
     
         45 : The method of  claim 44 , wherein the cancer is bladder cancer. 
     
     
         46 : The method of  claim 44 , wherein the cancer is lung cancer. 
     
     
         47 : The method of  claim 46 , wherein the lung is non-small cell lung cancer. 
     
     
         48 : The method of  claim 44 , wherein the cancer is breast cancer. 
     
     
         49 : The method of  claim 40 , wherein the subject has PD-L1 positive cancer. 
     
     
         50 : The method of  claim 40 , wherein the formulation is to be administered in conjunction with another therapeutic agent to the subject. 
     
     
         51 : The method of  claim 50 , wherein the therapeutic agent is a chemotherapeutic agent or an antibody treatment. 
     
     
         52 : A method of treating cancer in a subject comprising administering an effective amount of a stable aqueous pharmaceutical formulation comprising an anti-programmed death ligand 1 (anti-PD-L1) monoclonal antibody in a concentration of 60 mg/ml, histidine acetate in a concentration of 20 mM, sucrose in a concentration of 120 mM, polysorbate 20 in a concentration of 0.04% (w/v), and pH 5.8; wherein said monoclonal antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO:9, and a heavy chain comprising the amino acid sequence of SEQ ID NO:10. 
     
     
         53 : The method of  claim 52 , wherein the medicament is which is for intravenous (IV) administration. 
     
     
         54 : The method of  claim 52 , wherein the cancer is locally advanced or metastatic. 
     
     
         55 : The method of  claim 52 , wherein the cancer is selected from the group consisting of a solid tumor, a hematologic cancer, bladder cancer, brain cancer, breast cancer, colon cancer, colorectal cancer, gastric cancer, glioma, head cancer, leukemia, liver cancer, lung cancer, lymphoma, myeloma, neck cancer, ovarian cancer, melanoma, pancreatic cancer, renal cancer, salivary cancer, stomach cancer, thymic epithelial cancer, thyroid cancer, and squamous cell carcinoma of the head and neck. 
     
     
         56 : The method of  claim 55 , wherein the cancer is bladder cancer. 
     
     
         57 : The method of  claim 55 , wherein the cancer is lung cancer. 
     
     
         58 : The method of  claim 57 , wherein the lung is non-small cell lung cancer. 
     
     
         59 : The method of  claim 55 , wherein the cancer is breast cancer. 
     
     
         60 : The method of  claim 52 , wherein the subject has PD-L1 positive cancer. 
     
     
         61 : The method of  claim 52 , wherein the formulation is to be administered in conjunction with another therapeutic agent to the subject. 
     
     
         62 : The method of  claim 61 , wherein the therapeutic agent is a chemotherapeutic agent or an antibody treatment.