Claims for Patent: 10,993,942

Summary for Patent: 10,993,942

Title:	Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
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.
Inventor(s):	Sampath; Deepak (South San Francisco, CA), Klein; Christian (Iffeldorf, DE), Fairbrother; Wayne John (South San Francisco, CA), Enschede; Sari L. Heitner (River Forest, IL), Humerickhouse; Rod A. (Highland Park, IL), Roberts; Andrew W. (Melbourne, AU), Seymour; John F. (Melbourne, AU)
Assignee:	GENENTECH, INC. (South San Francisco, CA) HOFFMANN-LA ROCHE INC. (Little Falls, NJ) ABBVIE INC. (North Chicago, IL)
Application Number:	16/827,650
Patent Claims:	1. A method for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in a patient, the method comprising orally administering GDC-0199 in escalating doses to the patient, wherein the escalating doses comprise a dose of 50 mg of GDC-0199 per day for one week followed by a dose of 100 mg of GDC-0199 per day for one week. 2. The method of claim 1, wherein the escalating doses further comprise a dose of 20 mg of GDC-0199 per day for one week. 3. The method of claim 2, wherein the escalating doses further comprise a dose of 200 mg of GDC-0199 per day for one week. 4. The method of claim 1, wherein the escalating doses further comprise a dose of 300 mg of GDC-0199 per day for one week. 5. The method of claim 3, wherein the escalating doses further comprise a dose of 400 mg of GDC-0199 per day for one week. 6. The method of claim 1, wherein administration of GDC-0199 to the patient results in reduced tumor burden in the patient with acceptable toxicity. 7. The method of claim 1, wherein the GDC-0199 is administered in combination with a GA101 antibody. 8. The method of claim 7, wherein the GA101 antibody is obinutuzumab. 9. The method of claim 8, wherein an effective amount of the obinutuzumab is administered to the patient in combination with the GDC-0199 for 6 to 7 cycles of 28 days each cycle. 10. The method of claim 9, wherein the effective amount of the obinutuzumab is administered to the patient once every cycle for 6 to 7 cycles. 11. The method of claim 8, wherein a first dose of the obinutuzumab is administered to the patient as a split dose. 12. The method of claim 9, wherein the effective amount of the obinutuzumab is 500 mg to 3000 mg. 13. The method of claim 9, wherein the effective amount of the obinutuzumab is 1000 mg. 14. A method for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in a patient, the method comprising orally administering GDC-0199 in escalating doses to the patient, wherein the escalating doses comprise a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day. 15. The method of claim 14, wherein the method further comprises administering obinutuzumab to the patient. 16. The method of claim 15, wherein the obinutuzumab is administered to the patient at least once per cycle of 28 days for 6 cycles. 17. The method of claim 16, wherein the obinutuzumab is administered to the patient in the first cycle of the 6 cycles prior to administration of GDC-0199 to the patient. 18. The method of claim 17, wherein the first administration of the obinutuzumab to the patient is a split dose over two consecutive days prior to administration of GDC-0199 to the patient. 19. The method of claim 18, wherein the daily administration of GDC-0199 begins in the first cycle of the 6 cycles. 20. The method of claim 19, wherein the daily administration of GDC-0199 begins after the first week of the first cycle of the 6 cycles. 21. The method of claim 20, wherein obinutuzumab is administered once per cycle after the first cycle of the 6 cycles. 22. The method of claim 21, wherein the dose of 400 mg per day of GDC-0199 is administered to the patient through the last cycle of the 6 cycles. 23. The method of claim 22, wherein the obinutuzumab is administered on the first day of each cycle of the 6 cycles. 24. The method of claim 23, wherein the dose of 400 mg per day of GDC-0199 is administered to the patient as a monotherapy beyond the 6 cycles. 25. The method of claim 14, wherein administration of GDC-0199 to the patient results in reduced tumor burden in the patient with acceptable toxicity. 26. A method for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in a patient, the method comprising orally administering to the patient escalating doses of GDC-0199 during a dose escalation period, followed by orally administering to said patient 400 mg per day of GDC-0199, said escalating doses comprising 50 mg per day of GDC-0199 for one week followed by 100 mg per day of GDC-0199 for one week. 27. The method of claim 26, wherein said escalating doses further comprise 20 mg per day of GDC-0199 for one week and 200 mg per day of GDC-0199 for one week. 28. The method of claim 27, wherein the GDC-0199 is administered in combination with an effective amount of obinutuzumab. 29. The method of claim 28, wherein the effective amount of the obinutuzumab is 1000 mg. 30. The method of claim 26, wherein administration of GDC-0199 to the patient results in reduced tumor burden in the patient with acceptable toxicity.