IP Library Granted Patent US 11,896,596
Granted Patent B2
US 11,896,596 · App. 18/206,290 · Granted Feb 13, 2024

Methods of treating B-cell proliferative disorder

Inventors: Jason Paik (San Mateo, CA); Tommi Salmi (Cambridge, MA); Ying Ou (Palo Alto, CA); Motohisa Takai (Albany, CA)
Assignee: BeiGene Switzerland GmbH
A61K31/52A61K45/06A61P35/00
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Quick Facts
Patent No.
US 11,896,596
App. No.
18/206,290
Granted
Feb 13, 2024
Kind
B2
Abstract

Provided herein is a method of treating a patient having a B-cell proliferative disorder, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, wherein the patient is characterized by being administered with a moderate CYP3A inducer. In one embodiment, zanubrutinib is administered at a dose of about 320 mg twice a day, or at a total daily dose of about 640 mg.

Claims (38)

1. A method of treating or delaying progression of a B-cell proliferative disorder in a patient receiving a moderate CYP3A inducer, the method comprising

concomitantly administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer,

wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or follicular lymphoma (FL); and

the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

2. The method of claim 1 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

3. The method of claim 2 , wherein the moderate CYP3A inducer is rifabutin.

4. The method of claim 1 , wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL).

5. The method of claim 1 , wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM).

6. The method of claim 1 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

7. The method of claim 1 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

8. The method of claim 1 , wherein the moderate CYP3A inducer is rifabutin.

9. A method of treating or delaying progression of a B-cell proliferative disorder in a patient, the method comprising

selecting the patient who is being treated with a moderate CYP3A inducer; and

concomitantly administering to the selected patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer,

wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL).

10. The method of claim 9 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

11. The method of claim 9 , wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL).

12. The method of claim 9 , wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM).

13. The method of claim 9 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

14. The method of claim 9 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

15. The method of claim 9 , wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

16. The method of claim 15 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

17. The method of claim 16 , wherein the moderate CYP3A inducer is rifabutin.

18. A method of treating or delaying progression of a B-cell proliferative disorder in a patient receiving a moderate CYP3A inducer, the method comprising

assessing the patient as to whether the patient can avoid being treated with the moderate CYP3A inducer;

selecting the patient who cannot avoid being treated with the moderate CYP3A inducer; and

concomitantly administering to the selected patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer,

wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL).

19. The method of claim 18 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

20. The method of claim 18 , wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL).

21. The method of claim 18 , wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM).

22. The method of claim 18 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

23. The method of claim 18 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

24. The method of claim 18 , wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

25. The method of claim 24 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

26. He method of claim 25 , wherein the moderate CYP3A inducer is rifabutin.

27. The method of claim 9 , wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL).

28. The method of claim 18 , wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL).

Assignments (3)
CHANGE OF NAME Recorded Jun 27, 2025
From: BEIGENE SWITZERLAND GMBH
To: BEONE MEDICINES I GMBH
Reel/Frame 071544/0358 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 13, 2023
From: TAKAI, MOTOHISA
To: BEIGENE SWITZERLAND GMBH
Reel/Frame 065537/0455 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2023
From: PAIK, JASON; SALMI, TOMMI; OU, YING
To: BEIGENE SWITZERLAND GMBH
Reel/Frame 063866/0825 →
Continuity (7)
Continuation 18098938 · Jan 19, 2023
Provisional Application 63387796 · Dec 16, 2022
Provisional Application 63384864 · Nov 23, 2022
Provisional Application 63383504 · Nov 13, 2022
Provisional Application 63383503 · Nov 13, 2022
Provisional Application 63366053 · Jun 8, 2022
Related Publication 20230398122A1 · Dec 14, 2023
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