Claims for Patent: 10,751,342

Summary for Patent: 10,751,342

Title:	Use of inhibitors of Bruton's tyrosine kinase (Btk)
Abstract:	Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s):	Buggy; Joseph J. (Mountain View, CA), Fyfe; Gwen (San Francisco, CA), Honigberg; Lee (San Francisco, CA), Loury; David J. (Incline Village, NV)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	16/748,142
Patent Claims:	1. A method for treating relapsed or refractory CLL or SLL in an individual comprising orally administering to the individual a dose of 420 mg of an inhibitor of Bruton's tyrosine kinase (Btk) on a continuous once-daily regimen until progression of the CLL or SLL or unacceptable toxicity; and lymphocytosis is not considered progression of the CLL or SLL, wherein the inhibitor of Btk has the structure: ##STR00046## wherein the individual achieves a complete response. 2. The method of claim 1, wherein said administering results in an AUC.sub.(0-24) of >about 100 ng*h/ml. 3. The method of claim 1, wherein said administering results in >90% of the Btk active sites in the peripheral blood mononuclear cells of the individual being occupied by the inhibitor twenty-four hours following said administering. 4. The method of claim 1, wherein the once-daily regimen is continued for at least 6 months. 5. A method for treating CLL or SLL in an individual comprising orally administering to the individual a dose of 420 mg of an inhibitor of Bruton's tyrosine kinase (Btk) on a continuous once-daily regimen until progression of the CLL or SLL or unacceptable toxicity; and lymphocytosis is not considered progression of the CLL or SLL, wherein the inhibitor of Btk has the structure: ##STR00047## wherein the individual achieves a complete response. 6. The method of claim 5, wherein the individual is treatment nave. 7. The method of claim 5, wherein said administering results in an AUC.sub.(0-24) of >about 100 ng*h/ml. 8. The method of claim 5, wherein said administering results in >90% of the Btk active sites in the peripheral blood mononuclear cells of the individual being occupied by the inhibitor twenty-four hours following said administering. 9. The method of claim 5, wherein the once-daily regimen is continued for at least 6 months. 10. The method of claim 1, wherein the individual has relapsed or refractory CLL. 11. The method of claim 1, wherein the individual has relapsed or refractory SLL. 12. The method of claim 5, wherein the individual has relapsed or refractory CLL. 13. The method of claim 5, wherein the individual has relapsed or refractory SLL.