IP Library Granted Patent US 9,801,883
Granted Patent B2
US 9,801,883 · App. 15/054,952 · Granted Oct 31, 2017

Use of inhibitors of bruton's tyrosine kinase (Btk)

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Quick Facts
Patent No.
US 9,801,883
App. No.
15/054,952
Granted
Oct 31, 2017
Kind
B2
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.

Claims (34)

1. A method for treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in an individual in need thereof, wherein the individual is treatment-naïve for CLL/SLL, comprising:

administering to the individual once per day about 420 mg of an oral dose of a compound having the structure:

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 ≧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-naïve 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:

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-naïve for CLL.

27. The method of claim 25 , wherein the method is a method for treating SLL in an individual who is treatment-naïve 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.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 4, 2017
From: BUGGY, JOSEPH J.; ELIAS, LAURENCE; FYFE, GWEN; HEDRICK, ERIC; LOURY, DAVID J.; MODY, TARAK D.
To: PHARMACYCLICS, INC.
Reel/Frame 040843/0466 →
MERGER Recorded Jan 4, 2017
From: OXFORD AMHERST CORPORATION; PHARMACYCLICS, INC.
To: PHARMACYCLICS, INC.
Reel/Frame 040843/0487 →
MERGER AND CHANGE OF NAME Recorded Jan 4, 2017
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC; PHARMACYCLICS LLC
To: PHARMACYCLICS LLC
Reel/Frame 040843/0534 →