Combination of topoisomerase-i inhibitors with immunotherapy in the treatment of cancer

Abstract

The present disclosure relates to compositions and methods for treating cancer, more specifically to methods and compositions comprising a Topoisomerase I inhibitor and an α-PD-L1 antibody

1 .- 11 . (canceled) 
     
     
         12 . The A method of treatment of cancer in a host in need thereof, comprising administering to the host a combination of liposomal irinotecan and pembrolizumab for the treatment of cancer, in an amount and in a schedule of administration that is therapeutically synergistic in the treatment of said cancer. 
     
     
         13 . The method according to  claim 12 , wherein said schedule comprises administering to a human host during a 28-day treatment cycle: a total of 80 mg/m 2  liposomal irinotecan (free base) followed by the administration of 2 mg/kg pembrolizumab, once every two weeks for two weeks; and repeating said 28-day treatment cycle until a progression or an unacceptable toxicity is observed. 
     
     
         14 . The method according to  claim 12 , wherein said schedule comprises administering to a human host during a treatment cycle: a total of 43, 50, 70 or 80 mg/m 2  liposomal irinotecan (free base) once every two weeks for two weeks and administration of 2 mg/kg pembrolizumab once every three weeks; and repeating said treatment cycle until a progression or an unacceptable toxicity is observed. 
     
     
         15 . The method according to  claim 12 , wherein said schedule comprises administering to a human host during a treatment cycle: a total of 80 mg/m 2  liposomal irinotecan (free base) once every two weeks for two weeks and administration of 2 mg/kg pembrolizumab once every three weeks; and repeating said treatment cycle until a progression or an unacceptable toxicity is observed. 
     
     
         16 . The method according to  claim 12 , wherein the cancer is selected from the group consisting of melanoma, NSCLC and RCC. 
     
     
         17 . The method according to  claim 16 , wherein the cancer is melanoma. 
     
     
         18 . The method according to  claim 12 , wherein the liposomal irinotecan comprises liposomes having a unilamellar lipid bilayer vesicle, approximately 110 nm in diameter, which encapsulates an aqueous space containing irinotecan in a gelated or precipitated state as the sucrose octasulfate salt;
 wherein the vesicle is composed of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 6.81 mg/mL, cholesterol 2.22 mg/mL, and methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE) 0.12 mg/mL. MM-398.   
     
     
         19 . The method according to  claim 12  wherein no other antineoplastic agent is administered for the treatment of the cancer.