TEC FAMILY KINASE INHIBITOR ADJUVANT THERAPY
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.
1 - 34 . (canceled)
35 . A method of treating a myeloma or 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 myeloma or lymphoma is a relapsed or refractory myeloma or lymphoma.
37 . The method of claim 35 , wherein the lymphoma is non-Hodgkin's lymphoma.
38 . The method of claim 35 , wherein the myeloma is multiple myeloma.
39 . The method of claim 35 , wherein the lymphoma is mantle cell lymphoma.
40 . The method of claim 35 , wherein the myeloma is relapsed or refractory multiple myeloma.
41 . The method of claim 35 , wherein the lymphoma is relapsed or refractory mantle cell lymphoma.
42 . 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.
43 . 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.
44 . The method of claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject does not experience a relapse of the myeloma or 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.
45 . The method of claim 35 , wherein, following co-administration of ibrutinib and bortezomib, the subject experiences a reduced risk of relapsed or refractory myeloma or lymphoma as compared to a control subject who was administered bortezomib alone.
46 . The method of claim 42 , wherein the risk of relapsed or refractory myeloma or 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.
47 . 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.
48 . 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.
49 . The method of claim 35 , wherein the first amount of ibrutinib is about 300 mg per day to about 600 mg per day.
50 . The method of claim 35 , wherein the first amount of ibrutinib is about 420 mg per day.
51 . The method of claim 35 , wherein ibrutinib is administered once per day.
52 . The method of claim 35 , wherein ibrutinib is administered orally.
53 . The method of claim 35 , wherein ibrutinib is administered orally once per day.
54 . The method of claim 35 , wherein about 420 mg of ibrutinib is administered orally once per day.
55 . The method of claim 35 , wherein bortezomib is administered intravenously.
56 . A method of treating a myeloma or lymphoma in a subject in need thereof comprising co-administering:
a. a first amount of ibrutinib;
b. a second amount of bortezomib; and
c. a third amount of a corticosteroid,
wherein, together, the first amount of ibrutinib, the second amount of bortezomib, and the third amount of the corticosteroid are therapeutically effective.
57 . The method of claim 56 , wherein the corticosteroid is dexamethasone.
58 . The method of claim 57 , wherein the myeloma or lymphoma is a relapsed or refractory myeloma or lymphoma.
59 . The method of claim 57 , wherein the lymphoma is non-Hodgkin's lymphoma.
60 . The method of claim 57 , wherein the myeloma is multiple myeloma.
61 . The method of claim 57 , wherein the lymphoma is mantle cell lymphoma.
62 . The method of claim 57 , wherein the myeloma is relapsed or refractory multiple myeloma.
63 . The method of claim 57 , wherein the lymphoma is relapsed or refractory mantle cell lymphoma.
64 . The method of claim 57 , wherein, following co-administration of ibrutinib, bortezomib, and dexamethasone, the subject achieves a longer disease free survival (DFS) than a control subject who was co-administered bortezomib and dexamethasone.
65 . The method of claim 57 , wherein, following co-administration of ibrutinib, bortezomib, and dexamethasone, the subject achieves a longer overall survival (OS) than a control subject who was co-administered bortezomib and dexamethasone.
66 . The method of claim 57 , wherein, following co-administration of ibrutinib, bortezomib, and dexamethasone, the subject does not experience a relapse of the myeloma 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.
67 . The method of claim 57 , wherein, following co-administration of ibrutinib, bortezomib, and dexamethasone, the subject experiences a reduced risk of relapsed or refractory myeloma or lymphoma as compared to a control subject who was co-administered bortezomib and dexamethasone.
68 . The method of claim 67 , wherein the risk of relapsed or refractory myeloma 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.
69 . The method of claim 57 , wherein the subject experiences a decreased risk of developing a secondary tumor as compared to a control subject who was co-administered bortezomib and dexamethasone.
70 . The method of claim 57 , wherein, prior to co-administration of ibrutinib, bortezomib, and dexamethasone, 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.
71 . The method of claim 57 , wherein the first amount of ibrutinib is about 300 mg per day to about 600 mg per day.
72 . The method of claim 57 , wherein the first amount of ibrutinib is about 420 mg per day.
73 . The method of claim 57 , wherein ibrutinib is administered once per day.
74 . The method of claim 57 , wherein ibrutinib is administered orally.
75 . The method of claim 57 , wherein ibrutinib is administered orally once per day.
76 . The method of claim 57 , wherein about 420 mg of ibrutinib is administered orally once per day.
77 . The method of claim 57 , wherein bortezomib is administered intravenously.
78 . The method of claim 57 , wherein dexamethasone is administered orally.
79 . A method of treating a myeloma or lymphoma in a subject in need thereof comprising co-administering:
a. a first amount of ibrutinib, wherein the first amount is 300 mg to 600 mg; and
b. a second amount of bortezomib,
wherein ibrutinib is administered orally and bortezomib is administered intravenously; and wherein, together, the first amount of ibrutinib and the second amount of bortezomib are therapeutically effective.
80 . The method of claim 79 , wherein ibrutinib is administered once per day.
81 . The method of claim 79 , wherein the myeloma or lymphoma is a relapsed or refractory myeloma or lymphoma.
82 . The method of claim 79 , wherein the lymphoma is non-Hodgkin's lymphoma.
83 . The method of claim 79 , wherein the myeloma is multiple myeloma.
84 . The method of claim 79 , wherein the lymphoma is mantle cell lymphoma.
85 . The method of claim 79 , wherein the myeloma is relapsed or refractory multiple myeloma.
86 . The method of claim 79 , wherein the lymphoma is relapsed or refractory mantle cell lymphoma.
87 . The method of claim 79 , wherein the treatment further comprises co-administering:
c. a third amount of dexamethasone,
wherein, together, the first amount of ibrutinib, the second amount of bortezomib, and the third amount of dexamethasone are therapeutically effective.