IP Library Granted Patent US 11,911,386
Granted Patent B2
US 11,911,386 · App. 18/203,759 · Granted Feb 27, 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 11,911,386
App. No.
18/203,759
Granted
Feb 27, 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 (39)

1. A method of treating or delaying progression of a B-cell proliferative disorder in a patient, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a total daily dose of about 640 mg,

wherein the patient is characterized by being administered with a moderate CYP3A inducer; and

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).

2. The method of claim 1 , wherein zanubrutinib is administered at a dose of about 320 mg twice a day.

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

4. The method of claim 2 , wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL).

5. The method of claim 2 , wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM).

6. The method of claim 2 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

7. The method of claim 2 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

8. The method of claim 2 , wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

9. The method of claim 8 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

10. The method of claim 9 , wherein the moderate CYP3A inducer is rifabutin.

11. 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

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

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).

12. The method of claim 11 , wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL).

13. The method of claim 11 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

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

15. The method of claim 11 , wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM).

16. The method of claim 11 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

17. The method of claim 11 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

18. The method of claim 11 , wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

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

20. The method of claim 19 , wherein the moderate CYP3A inducer is rifabutin.

21. 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 receipt of the moderate CYP3A inducer can be avoided;

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

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

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).

22. The method of claim 21 , wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL).

23. The method of claim 21 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

24. The method of claim 21 , wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL).

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

26. The method of claim 21 , wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL).

27. The method of claim 21 , wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL).

28. The method of claim 21 , wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin.

29. The method of claim 28 , wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL).

30. The method of claim 29 , wherein the moderate CYP3A inducer is rifabutin.

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 065537/0422 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 31, 2023
From: PAIK, JASON; SALMI, TOMMI; OU, YING
To: BEIGENE SWITZERLAND GMBH
Reel/Frame 063811/0133 →
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 20230405013A1 · Dec 21, 2023