Claims for Patent: 9,801,883

Summary for Patent: 9,801,883

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), Elias; Laurence (Berkeley, CA), Fyfe; Gwen (San Fernando, CA), Hedrick; Eric (Summit, NJ), Loury; David J. (Incline, CA), Mody; Tarak D. (Sunnyvale, CA)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	15/054,952
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,801,883
Patent Claims:	1. A method for treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in an individual in need thereof, wherein the individual is treatment-naive for CLL/SLL, comprising: administering to the individual once per day about 420 mg of an oral dose of a compound having the structure: ##STR00046## 2. The method of claim 1, wherein the individual has high risk CLL. 3. The method of claim 1, wherein the individual has nucleic acid deletion in chromosome 17. 4. The method of claim 3, wherein the deletion is in 17p. 5. The method of claim 4, wherein the deletion is in 17p13. 6. The method of claim 1, wherein the individual has nucleic acid deletion in chromosome 11. 7. The method of claim 6, wherein the deletion is in 11q. 8. The method of claim 7, wherein the deletion is in 11q22. 9. The method of claim 1, further comprising administering to the individual an additional cancer treatment regimen. 10. The method of claim 9, wherein the additional cancer treatment regimen comprises bendamustine, bortezomib, CAL-101, chlorambucil, cyclophosphamide, dexamethasone, docetaxel, doxorubicin, endostatin, everolimus, etoposide, fludarabine, fostamatinib, hydroxydaunorubicin, ibritumomab, ifosphamide, lenalidomide, mesalazine, ofatumumab, paclitaxel, pentostatin, prednisone, rituximab, temsirolimus, thalidomide, tositumomab, vincristine, or a combination thereof. 11. The method of claim 1, further comprising administering to the individual rituximab. 12. The method of claim 1, further comprising administering to the individual bendamustine. 13. The method of claim 1, further comprising administering to the individual rituximab and bendamustine. 14. The method of claim 1, further comprising administering to the individual rituximab, fludarabine, and cyclophosphamide. 15. The method of claim 1, further comprising administering to the individual rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. 16. The method of claim 1, wherein the oral dose is a solid oral dosage form. 17. The method of claim 1, wherein the oral dose is a capsule. 18. The method of claim 1, wherein the individual is .gtoreq.65 years of age. 19. The method of claim 1, wherein the method is a method for treating CLL in an individual who is treatment-naive for CLL. 20. The method of claim 1, wherein the method is a method for treating SLL in an individual who is treatment-nave for SLL. 21. The method of claim 1, wherein, following administration of the compound, the individual achieves a stable disease, a partial response, or a complete response. 22. The method of claim 1, wherein, following administration of the compound, the individual achieves a partial response or a complete response. 23. The method of claim 1, wherein, following administration of the compound, the individual achieves a complete response. 24. The method of claim 1, wherein, following administration of the compound, the individual does not experience a progressive disease. 25. A method for treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in an individual in need thereof, wherein the individual is treatment-nave for CLL/SLL, comprising: administering to the individual once per day about 420 mg of an oral dose of a compound having the structure: ##STR00047## wherein the individual has a 17p deletion. 26. The method of claim 25, wherein the method is a method for treating CLL in an individual who is treatment-naive for CLL. 27. The method of claim 25, wherein the method is a method for treating SLL in an individual who is treatment-naive for SLL. 28. The method of claim 25, wherein, following administration of the compound, the individual achieves a stable disease, a partial response, or a complete response. 29. The method of claim 25, wherein, following administration of the compound, the individual achieves a partial response or a complete response. 30. The method of claim 25, wherein, following administration of the compound, the individual achieves a complete response. 31. The method of claim 25, wherein, following administration of the compound, the individual does not experience a progressive disease.