IP Library Granted Patent US 8,999,999
Granted Patent B2
US 8,999,999 · App. 13/747,322 · Granted Apr 7, 2015

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

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Quick Facts
Patent No.
US 8,999,999
App. No.
13/747,322
Granted
Apr 7, 2015
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 (18)

1. A method for treating relapsed or refractory chronic lymphocytic leukemia or relapsed or refractory small lymphocytic leukemia in an individual comprising administering to the individual in need thereof once per day between about 280 mg to about 840 mg of an oral dose of an irreversible inhibitor of Bruton's tyrosine kinase (Btk), having the structure:

2. The method of claim 1 , wherein the subject has high risk relapsed or refractory chronic lymphocytic leukemia.

3. The method of claim 1 , wherein the subject 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 subject 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, endostatineverolimus, 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 Btk inhibitor is administered orally.

17. The method of claim 1 , wherein the Btk inhibitor is in the form of a solid oral dosage form.

18. The method of claim 1 , wherein the once per day oral dose of the Btk inhibitor administered is about 280 mg/day, about 420 mg/day, about 560 mg/day, or about 840 mg/day.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED ON REEL 036058 FRAME 0429. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER. Recorded May 17, 2016
From: OXFORD AMHERST CORPORATION; PARMACYCLICS, INC.
To: PHARMACYCLICS, INC.
Reel/Frame 038722/0001 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED ON REEL 036058 FRAME 0755. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER AND CHANGE OF NAME. Recorded May 17, 2016
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC
To: PHARMACYCLICS LLC
Reel/Frame 038722/0043 →
MERGER Recorded Jul 10, 2015
From: OXFORD AMHERST CORPORATION
To: PHARMACYCLICS, INC.
Reel/Frame 036058/0429 →
MERGER AND CHANGE OF NAME Recorded Jul 10, 2015
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC
To: PHARMACYCLICS LLC
Reel/Frame 036058/0755 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2013
From: BUGGY, JOSEPH J.; ELIAS, LAURENCE; FYFE, GWEN; HEDRICK, ERIC; LOURY, DAVID J.; MODY, TARAK D.
To: PHARMACYCLICS, INC.
Reel/Frame 029720/0864 →