Claims for Patent: 10,544,224

Summary for Patent: 10,544,224

Title:	Method of treating cancer using immune checkpoint inhibitor
Abstract:	This disclosure provides a method for treating HPV-positive squamous cell carcinoma of the head and neck comprising administering to the subject an immune checkpoint inhibitor, e.g., an anti-PD-1 antibody or an anti-PD-L1 antibody. The disclosure also provides a method for treating HPV-negative squamous cell carcinoma of the head and neck administering to the subject an immune checkpoint inhibitor, e.g., an anti-PD-1 antibody or an anti-PD-L1 antibody. The subject can be additionally administered another anti-cancer agent.
Inventor(s):	Manekas; Demetrios (Princeton, NJ), Grosso; Joseph (Princeton, NJ), Anderson; Jeffrey (Princeton, NJ)
Assignee:	Bristol-Myers Squibb Company (Priceton, NJ)
Application Number:	15/210,612
Patent Claims:	1. A method for treating a human subject afflicted with a tumor derived from a human papilloma virus (HPV)-positive squamous cell carcinoma head and neck cancer (SCCHN) comprising administering to the subject a flat dose of 480 mg of nivolumab once every four weeks without regard for the weight of the subject. 2. A method of treating a human subject afflicted with a tumor derived from an HPV-positive SCCHN comprising: (i) measuring a level of HPV in a sample of the subject, wherein the subject is positive for HPV; and (ii) administering to the subject a flat dose of 480 mg of nivolumab once every four weeks without regard for the weight of the subject. 3. The method of claim 1, wherein the HPV-positive SCCHN comprises a tumor expressing one or more proteins derived from an HPV or comprising a nucleotide sequence encoding the one or more proteins. 4. The method of claim 3, wherein the one or more proteins derived from an HPV comprise p16, Ki-67, Cyclin D1, p53, ProEx C, E6, E7, or any combination thereof. 5. The method of claim 1, wherein the HPV comprises HPV subtype 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, or any combination thereof. 6. The method of claim 1, wherein more than about 70% of tumor cells in the tumor show strong and diffuse nuclear and cytoplasmic staining by an immunohistochemistry against p16. 7. The method of claim 1, wherein the tumor further expresses PD-L1. 8. The method of claim 1, wherein the subject exhibits an overall survival of at least about 10 months after the administration. 9. The method of claim 1, which further comprises administering one or more additional anti-cancer agents. 10. The method of claim 9, wherein at least one of the anti-cancer agents is selected from the group consisting of (i) an antibody or antigen-binding portion thereof that binds specifically to a CTLA-4 and inhibits CTLA-4 activity, (ii) a chemotherapy, (iii) a platinum-based doublet chemotherapy, (iv) a tyrosine kinase inhibitor, (v) an anti-VEGF inhibitor, and (vi) any combination thereof. 11. The method of claim 1, wherein the subject received one or more anti-cancer agents prior to the administration of the nivolumab. 12. The method of claim 11, wherein the one or more anti-cancer agents were not effective in treating the tumor. 13. The method of claim 12, wherein the one or more anti-cancer agents comprise a platinum-based therapy. 14. The method of claim 2, wherein the subject exhibits an overall survival of at least about 10 months after the administration. 15. The method of claim 2, wherein the HPV-positive SCCHN comprises a tumor expressing one or more proteins derived from an HPV or comprising a nucleotide sequence encoding the one or more proteins. 16. The method of claim 15, wherein the one or more proteins derived from an HPV comprise p16, Ki-67, Cyclin D1, p53, ProEx C, E6, E7, or any combination thereof. 17. The method of claim 2, wherein the HPV comprises HPV subtype 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, or any combination thereof. 18. The method of claim 2, wherein more than about 70% of tumor cells in the tumor show strong and diffuse nuclear and cytoplasmic staining by an immunohistochemistry against p16. 19. The method of claim 2, wherein the tumor further expresses PD-L1.

Details for Patent 10,544,224

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	December 22, 2014	10,544,224	2036-07-14
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	October 04, 2017	10,544,224	2036-07-14
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	August 27, 2021	10,544,224	2036-07-14

International Patent Family for US Patent 10,544,224

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017011666
United States of America	2024124592
United States of America	2020190198
United States of America	2017037132