US2020147084A1PendingUtilityA1

Tec family kinase inhibitor adjuvant therapy

Assignee: PHARMACYCLICS LLCPriority: Nov 2, 2012Filed: May 21, 2019Published: May 14, 2020
Est. expiryNov 2, 2032(~6.3 yrs left)· nominal 20-yr term from priority
A61P 29/00A61K 31/519A61P 43/00A61P 31/00A61P 35/02A61P 37/02A61P 37/00A61K 45/06A61P 35/00
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Claims

Abstract

Described herein are methods and compositions comprising a covalent TEC family kinase inhibitor for use in adjuvant therapy, including adjuvant cancer therapy, vaccination and treatment of immune disorders and pathogenic infections.

Claims

exact text as granted — not AI-modified
1 - 34 . (canceled) 
     
     
         35 . A method of treating a lymphoma in a subject in need thereof comprising co-administering:
 a. a first amount of ibrutinib; and   b. a second amount of bortezomib,   
       wherein, together, the first amount of ibrutinib and the second amount of bortezomib are therapeutically effective. 
     
     
         36 . The method of  claim 35 , wherein the lymphoma is a relapsed or refractory lymphoma. 
     
     
         37 . The method of  claim 35 , wherein the lymphoma is non-Hodgkin's lymphoma. 
     
     
         38 . The method of  claim 35 , wherein the lymphoma is mantle cell lymphoma. 
     
     
         39 . The method of  claim 35 , wherein the lymphoma is relapsed or refractory mantle cell lymphoma. 
     
     
         40 . The method of  claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject achieves a longer disease free survival (DFS) than a control subject who was administered bortezomib alone. 
     
     
         41 . The method of  claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject achieves a longer overall survival (OS) than a control subject who was administered bortezomib alone. 
     
     
         42 . The method of  claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject does not experience a relapse of the lymphoma for about 6 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years, about 7 years, about 8 years, about 9 years, or about 10 years. 
     
     
         43 . The method of  claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject experiences a reduced risk of relapsed or refractory lymphoma as compared to a control subject who was administered bortezomib alone. 
     
     
         44 . The method of  claim 43 , wherein the risk of relapsed or refractory lymphoma is reduced by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, or about 90% as compared to the control subject. 
     
     
         45 . The method of  claim 35 , wherein the subject experiences a decreased risk of developing a secondary tumor as compared to a control subject who was administered bortezomib alone. 
     
     
         46 . The method of  claim 35 , wherein, prior to co-administration of ibrutinib and bortezomib, the subject exhibits abnormal B-cell function, abnormal B-cell size, abnormal B-cell shape, abnormal B-cell count, fatigue, fever, night sweats, frequent infection, enlarged lymph nodes, paleness, anemia, loss of appetite, weight loss, bone or joint pain, headaches, or petechie. 
     
     
         47 . The method of  claim 35 , wherein the first amount of ibrutinib is about 300 mg per day to about 600 mg per day. 
     
     
         48 . The method of  claim 35 , wherein the first amount of ibrutinib is about 420 mg per day. 
     
     
         49 . The method of  claim 35 , wherein ibrutinib is administered once per day. 
     
     
         50 . The method of  claim 35 , wherein ibrutinib is administered orally. 
     
     
         51 . The method of  claim 35 , wherein ibrutinib is administered orally once per day. 
     
     
         52 . The method of  claim 35 , wherein about 420 mg of ibrutinib is administered orally once per day. 
     
     
         53 . The method of  claim 35 , wherein bortezomib is administered intravenously.

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