Claims for Patent: 11,911,386

Summary for Patent: 11,911,386

Title:	Methods of treating B-cell proliferative disorder
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.
Inventor(s):	Jason Paik, Tommi Salmi, Ying Ou, Motohisa Takai
Assignee:	BeiGene Switzerland GmbH
Application Number:	US18/203,759
Patent Claims:	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.