US2022175770A1PendingUtilityA1

Treatment of hepatocellular carcinoma characterized by hepatitis b virus infection

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Assignee: CELGENE CORPPriority: Jun 22, 2017Filed: Jul 20, 2021Published: Jun 9, 2022
Est. expiryJun 22, 2037(~10.9 yrs left)· nominal 20-yr term from priority
Inventors:Ellen FilvaroffKristen Mae HegeShaoyi Li
A61P 35/00A61K 39/3955A61K 2039/505A61K 31/44A61P 31/12A61K 31/4985A61K 31/4412A61P 31/20A61K 45/06A61K 2300/00A61K 31/517A61K 39/395
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Claims

Abstract

Provided herein are methods for treating and/or preventing hepatocellular carcinoma (HCC) characterized by hepatitis B virus (HBV) infection in a patient, comprising administering an effective amount of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one or a pharmaceutically acceptable salt or tautomer thereof (collectively referred to herein as “Compound 1”) to the patient having HCC characterized by HBV infection.

Claims

exact text as granted — not AI-modified
1 - 45 . (canceled) 
     
     
         46 . A method for treating hepatocellular carcinoma (HCC) characterized by hepatitis B virus (HBV) infection in a patient, comprising administering an effective amount of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one or a pharmaceutically acceptable salt or tautomer thereof to the patient having HCC characterized by HBV infection;
 wherein 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one or a pharmaceutically acceptable salt or tautomer thereof is administered in combination with a second therapeutic agent;   and wherein the second therapeutic agent is an anti-CTLA-4 antibody.   
     
     
         47 . The method of  claim 46 , wherein the anti-CTLA-4 antibody is ipilimumab. 
     
     
         48 . The method of  claim 46 , wherein HBV infection is determined by at least one of the variables selected from the group consisting of: patient history of HBV, prior or current treatment for HBV, cirrhosis attributed to HBV, the presence of HBV proteins or antigens, the presence of antibodies to HBV proteins or antigens, HBV viral load, and the presence of HBV DNA. 
     
     
         49 . The method of  claim 46 , wherein HBV infection is determined by patient history of HBV. 
     
     
         50 . The method of  claim 46 , wherein HBV infection is determined by prior treatment for HBV. 
     
     
         51 . The method of  claim 46 , wherein HBV infection is determined by current treatment for HBV. 
     
     
         52 . The method of  claim 46 , wherein HBV infection is determined by cirrhosis attributed to HBV. 
     
     
         53 . The method of  claim 46 , wherein HBV infection is determined by the presence of HBV proteins or antigens. 
     
     
         54 . The method of  claim 46 , wherein HBV infection is determined by the presence of antibodies to HBV proteins or antigens. 
     
     
         55 . The method of  claim 46 , wherein HBV infection is determined by HBV viral load. 
     
     
         56 . The method of  claim 46 , wherein HBV infection is determined by the presence of HBV DNA. 
     
     
         57 . The method of  claim 46 , wherein HBV infection is determined by at least one of the variables selected from the group consisting of the presence of HBV surface antigen (HBsAG), the presence of HBV core antigen (HBcAG), the presence of HBV envelope antigen (HBeAg), the presence of HBV x antigen (HBxAg), the presence of HBV core-related antigen (HBcrAg), the presence of antibody to HBV surface antigen (anti-HBsAg), the presence of antibody to HBV core antigen (anti-HBcAg), the presence of antibody to HBV envelope antigen (anti-HBeAg), the presence of antibody to HBV x antigen (anti-HBxAg), the presence of antibody to HBV core-related antigen (anti-HBcrAg), the use of HBV medications, HBV viral load, the presence of HBV DNA, the presence of HBV mRNA, and the presence of HBV protein. 
     
     
         58 . The method of  claim 46 , wherein the HCC is unresectable HCC. 
     
     
         59 . The method of  claim 46 , wherein the HCC is previously untreated HCC. 
     
     
         60 . The method of  claim 46 , wherein the HCC is previously treated HCC, wherein the previous treatment comprises sorafenib. 
     
     
         61 . The method of  claim 46 , wherein the HCC is previously treated HCC, wherein the previous treatment comprises chemotherapy.

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