Claims for Patent: 10,869,924

Summary for Patent: 10,869,924

Title:	PD-L1 antagonist combination treatments
Abstract:	The present disclosure describes combination therapies comprising an antagonist of Programmed Death Ligand 1 receptor (PD-L1) and another therapeutic agent, and the use of the combination therapies for the treatment of cancer.
Inventor(s):	Andrews; Glen Ian (San Diego, CA), Chen; Shihao (Foster City, CA), Di Pietro; Alessandra (Opera, IT), Fontana; David (Clyde Hill, WA), Goldberg; Zelanna (San Diego, CA), Lin; Chia-Yang (Palo Alto, CA), Long; Hua (San Carlos, CA), Martignoni; Marcella (Milan, IT), Nuyten; Dimitry Serge Antoine (San Francisco, CA), Thall; Aron David (San Diego, CA), Woolfson; Adrian (New York, NY)
Assignee:	MERCK PATENT GMBH (Darmstadt, DE) PFIZER INC. (New York, NY)
Application Number:	15/736,615
Patent Claims:	1. A method for treating a cancer in a human subject comprising administering to the subject a combination therapy which comprises an antagonist of a Programmed Death Ligand 1 protein (PD-L1) and a VEGFR inhibitor, wherein the PD-L1 antagonist is an anti-PD-L1 monoclonal antibody comprising: three CDRs from a heavy chain variable region comprising the amino acid sequence shown in SEQ ID NO: 8, and three CDRs from a light chain variable region comprising the amino acid sequence shown in SEQ ID NO: 9, wherein the VEGFR inhibitor is N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzami- de or a pharmaceutically acceptable salt thereof and wherein the cancer is renal cell carcinoma. 2. The method of claim 1, wherein the PD-L1 antagonist is avelumab and the VEGFR inhibitor is axitinib. 3. The method of claim 2, wherein the PD-L1 antagonist is administered as an initial dose of at least about 5 mg/kg, or about 10 mg/kg; and the VEGFR inhibitor is administered as an initial dose of at least 3 mg or 5 mg. 4. The method of claim 3, wherein the PD-L1 antagonist is administered about once every two weeks; and the VEGFR inhibitor is administered twice daily. 5. The method of claim 1, wherein the renal cell carcinoma is advanced renal cell carcinoma. 6. The method of claim 5, wherein the advanced renal cell carcinoma is previously untreated advanced renal cell carcinoma. 7. The method of claim 2, wherein the PD-L1 antagonist is administered about once every two weeks. 8. The method of claim 7, wherein the PD-L1 antagonist is administered at a dose of about 10 mg/kg. 9. The method of claim 2, wherein the VEGFR inhibitor is administered twice daily. 10. The method of claim 9, wherein the VEGFR inhibitor is administered at a dose of 5 mg. 11. The method of claim 2, wherein the PD-L1 antagonist is administered as a 1-hour intravenous infusion. 12. The method of claim 2, wherein administration of the PD-L1 antagonist and the VEGFR inhibitor is discontinued if unacceptable toxicity occurs. 13. The method of claim 2, wherein administration of the PD-L1 antagonist and the VEGFR inhibitor is discontinued if disease progression occurs. 14. A method for treating renal cell carcinoma in a human subject comprising administering to the subject a combination therapy which comprises avelumab and axitinib, wherein avelumab is administered about once every two weeks, and axitinib is administered twice daily. 15. The method of claim 14, wherein avelumab is administered at a dose of about 10 mg/kg. 16. The method of claim 14, wherein axitinib is administered at a dose of 5 mg. 17. The method of claim 14, wherein avelumab is administered at a dose of about 10 mg/kg, and axitinib is administered at a dose of 5 mg. 18. The method of claim 14, wherein avelumab is administered as a 1-hour intravenous infusion. 19. The method of claim 14, wherein the administration of avelumab and axitinib is discontinued if unacceptable toxicity occurs. 20. The method of claim 14, wherein the administration of avelumab and axitinib is discontinued if disease progression occurs. 21. A method for treating renal cell carcinoma in a human subject comprising administering to the subject a combination therapy which comprises avelumab and axitinib, wherein avelumab is administered about once every two weeks as a 1-hour intravenous infusion. 22. The method of claim 21, wherein avelumab is administered at a dose of about 10 mg/kg. 23. The method of claim 21, wherein axitinib is administered twice daily. 24. The method of claim 23, wherein axitinib is administered at a dose of 5 mg.