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Last Updated: August 11, 2020

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Claims for Patent: 9,730,938

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Summary for Patent: 9,730,938
Title:Bruton\'s tyrosine kinase inhibitor combinations and uses thereof
Abstract: Disclosed herein are methods, compositions, and kits for treating a B-cell malignancy comprising administering a combination of a BTK inhibitor (e.g. ibrutinib) and a PIM inhibitor. Also disclosed herein are methods, compositions, and kits for treating a BTK-resistant B-cell malignancy comprising administering a combination of a BTK inhibitor (e.g. ibrutinib) and a PIM inhibitor.
Inventor(s): Kuo; Hsu-Ping (Sunnyvale, CA), Hsieh; Hsin-Kang (San Jose, CA), Chang; Betty (Cupertino, CA), Xue; Ling (Beijing, CN), Balasubramanian; Sriram (North Wales, PA), Cheung; Leo (Fremont, CA)
Assignee: Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE)
Application Number:14/820,434
Patent Claims:1. A method of treating a B-cell malignancy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a combination comprising ibrutinib and a PIM inhibitor selected from SGI-1776, AZD1208, AZD1897, LGH447, JP_11646, CX-6258, and K00135, wherein the B-cell malignancy is acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), high-risk small lymphocytic lymphoma (SLL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia, multiple myeloma, extranodal marginal zone B cell lymphoma, nodal marginal zone B cell lymphoma, Burkitt's lymphoma, non-Burkitt high grade B cell lymphoma, primary mediastinal B-cell lymphoma (PMBL), immunoblastic large cell lymphoma, precursor B-lymphoblastic lymphoma, B cell prolymphocytic leukemia, lymphoplasmacytic lymphoma, splenic marginal zone lymphoma, plasma cell myeloma, plasmacytoma, mediastinal (thymic) large B cell lymphoma, intravascular large B cell lymphoma, primary effusion lymphoma, or lymphomatoid granulomatosis.

2. The method of claim 1, wherein the combination provides a synergistic effect compared to administration of ibrutinib or the PIM inhibitor alone.

3. The method of claim 1, wherein the combination sensitizes the B-cell malignancy to ibrutinib.

4. The method of claim 1, wherein the PIM inhibitor is AZD1208.

5. The method of claim 1, wherein the B-cell malignancy is diffuse large B-cell lymphoma (DLBCL).

6. The method of claim 5, wherein the DLBCL is activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL).

7. The method claim 1, wherein the method further comprises administering a third therapeutic agent.

8. The method of claim 7, wherein the third therapeutic agent is a chemotherapeutic agent or a radiation therapeutic agent.

9. The method of claim 8, wherein the third therapeutic agent is a chemotherapeutic agent; and the chemotherapeutic agent is chlorambucil, ifosfamide, doxorubicin, mesalazine, thalidomide, lenalidomide, temsirolimus, everolimus, fludarabine, fostamatinib, paclitaxel, docetaxel, ofatumumab, rituximab, dexamethasone, prednisone, CAL-101, ibritumomab, tositumomab, bortezomib, pentostatin, endostatin, or a combination thereof.

10. The method of claim 1, wherein the B-cell malignancy is diffuse large B-cell lymphoma (DLBCL); and the PIM inhibitor is AZD1208.

11. The method of claim 10, wherein the DLBCL is activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL).

12. The method of claim 1, wherein the PIM inhibitor is SGI-1776.

13. The method of claim 1, wherein the PIM inhibitor is AZD1897.

14. The method of claim 1, wherein the PIM inhibitor is LGH447.

15. The method of claim 1, wherein the PIM inhibitor is JP_11646.

16. The method of claim 1, wherein the PIM inhibitor is CX-6258.

17. The method of claim 1, wherein the PIM inhibitor is K00135.

18. The method of claim 1, wherein, following administration of ibrutinib and the PIM inhibitor, the subject achieves a complete response (CR), exhibits a stable disease (SD), or does not exhibit progressive disease (PD).

19. The method of claim 1, wherein, following administration of ibrutinib and the PIM inhibitor, the subject achieves a complete response (CR).

20. The method of claim 1, wherein, following administration of ibrutinib and the PIM inhibitor, the subject does not exhibit progressive disease within 12 months.

21. The method of claim 10, wherein, following administration of ibrutinib and the PIM inhibitor, the subject achieves a complete response (CR), exhibits a stable disease (SD), or does not exhibit progressive disease (PD).

22. The method of claim 10, wherein, following administration of ibrutinib and the PIM inhibitor, the subject achieves a complete response (CR).

23. The method of claim 10, wherein, following administration of ibrutinib and the PIM inhibitor, the subject does not exhibit progressive disease within 12 months.

Details for Patent 9,730,938

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Genentech RITUXAN rituximab SOLUTION;INTRAVENOUS 103705 001 1997-11-26   Start Trial Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE) 2034-08-08 RX search
Genentech RITUXAN rituximab SOLUTION;INTRAVENOUS 103705 002 1997-11-26   Start Trial Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE) 2034-08-08 RX search
Novartis ARZERRA ofatumumab INJECTABLE; INJECTION 125326 001 2009-10-26   Start Trial Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE) 2034-08-08 RX search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 001 2017-06-22   Start Trial Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE) 2034-08-08 RX Orphan search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 002 2017-06-22   Start Trial Pharmacyclics LLC (Sunnyvale, CA) Janssen Pharmaceutica NV (Beerse, BE) 2034-08-08 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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