IP Library Granted Patent US 9,724,413
Granted Patent B2
US 9,724,413 · App. 14/236,064 · Granted Aug 8, 2017

Methods of treating cancer using PD-1 axis binding antagonists and MEK inhibitors

Inventors: Heather Maecker (Palo Alto, CA); Bryan Irving (San Francisco, CA)
Assignee: Genentech, Inc.
A61K39/39558A61K31/4184A61K31/4355A61K31/44A61K31/4523A61K31/519A61K47/48238C07K16/2827C07K16/3046C07K16/3053A61K2039/505
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Quick Facts
Patent No.
US 9,724,413
App. No.
14/236,064
Granted
Aug 8, 2017
Kind
B2
Abstract

The present invention describes combination treatment comprising a PD-1 axis binding antagonist and a MEK inhibitor and methods for use thereof, including methods of treating conditions where enhanced immunogenicity is desired such as increasing tumor immunogenicity for the treatment of cancer.

Claims (33)

1. A method for treating or delaying progression of colorectal cancer or melanoma in an individual comprising administering to the individual an effective amount of an anti-PD-L1 antibody and a MEK inhibitor, wherein the MEK inhibitor is selected from the group consisting of G02442104, G-38963, G02443714, G00039805 and GDC-0973, or a pharmaceutically acceptable salt or solvate thereof.

2. The method of claim 1 , wherein the anti-PD-L1 antibody inhibits the binding of PD-L1 to PD-1.

3. The method of claim 1 , wherein the anti-PD-L1 antibody inhibits the binding of PD-L1 to B7-1.

4. The method of claim 1 , wherein the anti-PD-L1 antibody inhibits the binding of PD-L1 to both PD-1 and B7-1.

5. The method of claim 1 , wherein the anti-PD-L1 antibody is selected from the group consisting of: YW243.55.S70, MPDL3280A, and MDX-1105.

6. The method of claim 1 , wherein the anti-PD-L1 antibody comprises a heavy chain comprising HVR-H1 sequence of SEQ ID NO:15, HVR-H2 sequence of SEQ ID NO:16, and HVR-H3 sequence of SEQ ID NO:3; and a light chain comprising HVR-L1 sequence of SEQ ID NO:17, HVR-L2 sequence of SEQ ID NO:18, and HVR-L3 sequence of SEQ ID NO:19.

7. The method of claim 1 , wherein the anti-PD-L1 antibody comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:24 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:21.

8. The method of claim 1 , wherein the MEK inhibitor is G02443714, G02442104 or G00039805.

9. The method of claim 1 , wherein the cancer contains a BRAF V600E mutation.

10. The method of claim 1 , wherein the cancer contains a BRAF wildtype.

11. The method of claim 1 , wherein the colorectal cancer contains a KRAS wildtype.

12. The method of claim 1 , wherein the colorectal cancer contains an activating KRAS mutation.

13. The method of claim 1 , wherein the treatment results in a sustained response in the individual after cessation of the treatment.

14. The method of claim 1 , wherein the MEK inhibitor is administered continuously.

15. The method of claim 1 , wherein the MEK inhibitor is administered intermittently.

16. The method of claim 1 , wherein the MEK inhibitor is administered before the anti-PD-L1 antibody.

17. The method of claim 1 , wherein the MEK inhibitor is administered simultaneous with the anti-PD-L1 antibody.

18. The method of claim 1 , wherein the MEK inhibitor is administered after the anti-PD-L1 antibody.

19. The method of claim 1 , wherein the anti-PD-L1 antibody is a monoclonal antibody.

20. The method of claim 1 , wherein the anti-PD-L1 antibody is a humanized antibody.

21. The method of claim 1 , wherein the anti-PD-L1 antibody is a human antibody.

22. The method of claim 1 , wherein the anti-PD-L1 antibody is administered intravenously, intramuscularly, subcutaneously, topically, orally, transdermally, intraperitoneally, intraorbitally, by implantation, by inhalation, intrathecally, intraventricularly, or intranasally.

23. A method for treating or delaying progression of colorectal cancer in an individual comprising administering to the individual an effective amount of GDC-0973, or a pharmaceutically acceptable salt thereof, and an effective amount of an anti-PD-L1 antibody, wherein the anti-PD-L1 antibody comprises a heavy chain comprising an HVR-H1 sequence of SEQ ID NO:15, an HVR-H2 sequence of SEQ ID NO:16, and an HVR-H3 sequence of SEQ ID NO:3; and a light chain comprising an HVR-L1 sequence of SEQ ID NO:17;, an HVR-L2 sequence of SEQ ID NO:18, and an HVR-L3 sequence of SEQ ID NO:19.

24. The method of claim 23 , wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:24 and the light chain comprises a light chain variable domain comprising the amino acid sequence of SEQ ID NO:21.

25. The method of claim 23 , wherein the anti-PDL1 antibody is MPDL3280A.

26. A method for treating or delaying progression of melanoma in an individual comprising administering to the individual an effective amount of GDC-0973, or a pharmaceutically acceptable salt thereof, and an effective amount of an anti-PD-L1 antibody, wherein the melanoma is BRAF wildtype, and wherein the anti-PD-L1 antibody comprises a heavy chain comprising an HVR-H1 sequence of SEQ ID NO:15, an HVR-H2 sequence of SEQ ID NO:16, and an HVR-H3 sequence of SEQ ID NO:3; and a light chain comprising an HVR-L1 sequence of SEQ ID NO:17, an HVR-L2 sequence of SEQ ID NO:18, and an HVR-L3 sequence of SEQ ID NO:19.

27. The method of claim 26 , wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:24 and the light chain comprises a light chain variable domain comprising the amino acid sequence of SEQ ID NO:21.

28. The method of claim 26 , wherein the anti-PDL1 antibody is MPDL 3280A.

29. The method of claim 1 , wherein the MEK inhibitor is s G02442104, or a pharmaceutically acceptable salt or solvate thereof.

30. The method of claim 1 , wherein the MEK inhibitor is G-38963, or a pharmaceutically acceptable salt or solvate thereof.

31. The method of claim 1 , wherein the MEK inhibitor is G02443714, or a pharmaceutically acceptable salt or solvate thereof.

32. The method of claim 1 , wherein the MEK inhibitor is G00039805, or a pharmaceutically acceptable salt or solvate thereof.

33. The method of claim 1 , wherein the MEK inhibitor is GDC-0973, or a pharmaceutically acceptable salt or solvate thereof.

Continuity (2)
Provisional Application 61574406 · Aug 1, 2011
Related Publication 20140341902A1 · Nov 20, 2014