IP Library Granted Patent US 10,004,746
Granted Patent B2
US 10,004,746 · App. 15/659,803 · Granted Jun 26, 2018

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

Inventors: Joseph J. Buggy (Mountain View, CA); Laurence Elias (Berkeley, CA); Gwen Fyfe (San Francisco, CA); Eric Hedrick (Summit, NJ); David J. Loury (Incline Village, NV); Tarak D. Mody (Sunnyvale, CA)
Assignee: Pharmacyclics LLC
A61K31/519A61K9/06A61K31/195A61K31/337A61K31/4184A61K31/436A61K31/437A61K31/454A61K31/475A61K31/4745A61K31/573A61K31/606A61K31/664A61K31/675A61K31/69A61K31/704A61K31/7032A61K31/7076A61K39/395C07D487/04
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Quick Facts
Patent No.
US 10,004,746
App. No.
15/659,803
Granted
Jun 26, 2018
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 (30)

1. A method for treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in an individual who has failed at least one prior therapy for chronic lymphocytic leukemia or small lymphocytic lymphoma comprising administering to the individual once per day about 420 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase (Btk) having the structure:

2. The method of claim 1 , wherein the oral dose is a capsule.

3. The method of claim 1 , wherein, following administration of the inhibitor, the individual achieves a stable disease, a partial response, or a complete response.

4. The method of claim 1 , wherein, following administration of the inhibitor, the individual achieves a partial response or a complete response.

5. The method of claim 1 , wherein, following administration of the inhibitor, the individual achieves a complete response.

6. The method of claim 1 , wherein, following administration of the inhibitor, the individual does not experience a progressive disease.

7. The method of claim 3 , wherein the method is a method of treating chronic lymphocytic leukemia (CLL).

8. The method of claim 3 , wherein the method is a method of treating small lymphocytic lymphoma (SLL).

9. The method of claim 1 , wherein the individual has nucleic acid deletion in chromosome 17.

10. The method of claim 9 , wherein the deletion is in 17p.

11. A method for treating relapsed or refractory chronic lymphocytic leukemia (CLL)/relapsed or refractory small lymphocytic lymphoma (SLL) in an individual comprising administering to the individual in need thereof once per day about 420 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase (Btk) having the structure:

12. The method of claim 11 , wherein the oral dose is a capsule.

13. The method of claim 11 , wherein, following administration of the inhibitor, the individual achieves a stable disease, a partial response, or a complete response.

14. The method of claim 11 , wherein, following administration of the inhibitor, the individual achieves a partial response or a complete response.

15. The method of claim 11 , wherein, following administration of the inhibitor, the individual achieves a complete response.

16. The method of claim 11 , wherein, following administration of the inhibitor, the individual does not experience a progressive disease.

17. The method of claim 13 , wherein the method is a method of treating relapsed or refractory chronic lymphocytic leukemia (CLL).

18. The method of claim 13 , wherein the method is a method of treating relapsed or refractory small lymphocytic lymphoma (SLL).

19. The method of claim 11 , wherein the individual has nucleic acid deletion in chromosome 17.

20. The method of claim 19 , wherein the deletion is in 17p.

21. A method for treating small lymphocytic lymphoma (SLL) in an individual who has failed at least one prior therapy for small lymphocytic lymphoma comprising administering to the individual once per day about 420 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase (Btk) having the structure:

22. The method of claim 21 , wherein, following administration of the inhibitor, the individual achieves a partial response or a complete response.

23. The method of claim 21 , wherein, following administration of the inhibitor, the individual achieves a complete response.

24. The method of claim 21 , wherein, following administration of the inhibitor, the individual does not experience a progressive disease.

25. The method of claim 21 , wherein the individual has nucleic acid deletion in chromosome 17p.

26. A method for treating relapsed or refractory small lymphocytic lymphoma (SLL) in an individual comprising administering to the individual in need thereof once per day about 420 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase (Btk) having the structure:

27. The method of claim 26 , wherein, following administration of the inhibitor, the individual achieves a partial response or a complete response.

28. The method of claim 26 , wherein, following administration of the inhibitor, the individual achieves a complete response.

29. The method of claim 26 , wherein, following administration of the inhibitor, the individual does not experience a progressive disease.

30. The method of claim 26 , wherein the individual has nucleic acid deletion in chromosome 17p.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2017
From: BUGGY, JOSEPH J.; ELIAS, LAURENCE; FYFE, GWEN; HENDRICK, ERIC; LOURY, DAVID J.; MODY, TARAK D.
To: PHARMACYCLICS, INC.
Reel/Frame 043157/0463 →
MERGER Recorded Aug 1, 2017
From: OXFORD AMHERST CORPORATION; PHARMACYCLICS, INC.
To: PHARMACYCLICS, INC.
Reel/Frame 043157/0467 →
MERGER AND CHANGE OF NAME Recorded Aug 1, 2017
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC; PHARMACYCLICS LLC
To: PHARMACYCLICS LLC
Reel/Frame 043157/0483 →
Continuity (10)
Continuation 14091196 · Nov 26, 2013
Continuation 13869700 · Apr 24, 2013
Continuation 13153317 · Jun 3, 2011
Provisional Application 61472138 · Apr 5, 2011
Provisional Application 61419764 · Dec 3, 2010
Provisional Application 61351655 · Jun 4, 2010
Provisional Application 61351793 · Jun 4, 2010
Provisional Application 61351762 · Jun 4, 2010
Provisional Application 61351130 · Jun 3, 2010
Related Publication 20180015091A1 · Jan 18, 2018
Cited By (1)
US 12,551,448