Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor

Patent metadata

Field	Value
Publication number	US-11110087-B2
Application number	US-202117187468-A
Country	US
Kind code	B2
Filing date	Feb 26, 2021
Priority date	Sep 7, 2012
Publication date	Sep 7, 2021
Grant date	Sep 7, 2021

Abstract

The present invention is directed to a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the treatment of a patient suffering from cancer, particularly, a CD20-expressing cancer.

First claim

What is claimed is:

1. A method for treating lymphoma or leukemia in a human patient, the method comprising orally administering once daily GDC-0199 to the patient in dosing cycles comprising escalating doses, wherein the escalating doses comprise a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.

2. The method of claim 1 , wherein each dosing cycle is one day.

3. The method of claim 2 , wherein a starting dose of the escalating doses is administered for one dosing cycle and an ending dose of the escalating doses is administered in multiple dosing cycles.

4. The method of claim 3 , wherein the method is continued until disease progression.

5. The method of claim 1 , wherein the GDC-0199 is administered in combination with obinutuzumab.

6. The method of claim 5 , wherein an effective amount of the obinutuzumab is administered to the patient in combination with the GDC-0199 once in a 28 day cycle for 6 to 7 dosing cycles.

7. The method of claim 6 , wherein the effective amount of the obinutuzumab is 1000 mg.

8. The method of claim 1 , wherein the patient is administered 100 mg of GDC-0199 per day for one day, followed by 200 mg of GDC-0199 per day for one day, followed by 400 mg of GDC-0199 per day.

9. A method for treating lymphoma or leukemia in a human patient, the method comprising orally administering once daily GDC-0199 in escalating doses to the patient, wherein the escalating doses comprise a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC-0199 per day.

10. The method of claim 9 , wherein the method comprises administering three differing doses of GDC-0199.

11. The method of claim 10 , wherein the method comprises administering GDC-0199 in multiple dosing cycles and wherein a different dose of GDC-0199 is orally administered once daily to the patient in each of the first three dosing cycles.

12. The method of claim 11 , wherein each dosing cycle is one day.

13. The method of claim 12 , wherein a starting dose of the escalating doses is administered for one dosing cycle and an ending dose of the escalating doses is administered in multiple dosing cycles.

14. The method of claim 13 , wherein the method is continued until disease progression.

15. The method of claim 9 , wherein the GDC-0199 is administered in combination with obinutuzumab.

16. The method of claim 15 , wherein an effective amount of the obinutuzumab is administered to the patient in combination with the GDC-0199 once in a 28 day cycle for 6 to 7 dosing cycles.

17. The method of claim 16 , wherein the effective amount of the obinutuzumab is 1000 mg.

18. The method of claim 9 , wherein the patient is administered 100 mg of GDC-0199 per day for one day, followed by 200 mg of GDC-0199 per day for one day.

19. A method for treating lymphoma or leukemia in a human patient, the method comprising orally administrating once daily GDC-0199 in escalating doses to the patient, wherein the escalating doses comprise a daily dose of 100 mg of GDC-0199.

20. The method of claim 19 , wherein the method comprises administering three differing doses of GDC-0199.

21. The method of claim 20 , wherein the dose of 100 mg of GDC-0199 is a starting dose of the escalating doses.

22. The method of claim 20 , wherein the method comprises administering GDC-0199 in multiple dosing cycles and wherein a different dose of GDC-0199 is orally administered once daily to the patient in each of the first three dosing cycles.

23. The method of claim 22 , wherein each dosing cycle is one day.

24. The method of claim 20 , wherein a starting dose of the escalating doses is administered for one dosing cycle and an ending dose of the escalating doses is administered in multiple dosing cycles.

25. The method of claim 24 , wherein the method is continued until disease progression.

26. The method of claim 19 , wherein the GDC-0199 is administered in combination with cytarabine.

27. The method of claim 19 , wherein the GDC-0199 is administered in combination with obinutuzumab.

28. The method of claim 27 , wherein an effective amount of the obinutuzumab is administered to the patient in combination with the GDC-0199 once in a 28 day cycle for 6 to 7 dosing cycles.

29. The method of claim 28 , wherein the effective amount of the obinutuzumab is 1000 mg.

Assignees

• Genentech Inc
• Hoffmann La Roche
• Abbvie Inc

Inventors

• Sampath Deepak
• Klein Christian
• Fairbrother Wayne John
• Enschede Sari L Heitner
• Humerickhouse Rod A
• Roberts Andrew W
• Seymour John F

Classifications

• A61K39/395 Primary

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title

• A61K31/63

  Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide · CPC title

• A61K31/45

  having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide · CPC title

• A61K31/4375

  the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine · CPC title

• A61K31/33

  Heterocyclic compounds · CPC title