Claims for Patent: 10,034,938

Summary for Patent: 10,034,938

Title:	Method for treating melanoma using a herpes simplex virus and an immune checkpoint inhibitor
Abstract:	The invention relates to methods of treating melanoma using a herpes simplex virus in combination with an immune checkpoint inhibitor.
Inventor(s):	Vanderwalde; Ari (Memphis, TN), Shabooti; Mohamed (Agoura Hills, CA)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	14/424,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,034,938
Patent Claims:	1. A method for the treatment of melanoma, said method comprising administering to a patient with stages IIIb to IV melanoma: (i) an effective amount of an anti-PD-1 antibody or anti-CTLA-4 antibody; and (ii) a herpes simplex virus, wherein said herpes simplex virus: lacks a functional ICP34.5 encoding gene; lacks a functional ICP47 encoding gene; and comprises a gene encoding human GM-CSF. 2. A kit comprising: (i) a herpes simplex virus, wherein said herpes simplex virus: lacks a functional ICP34.5 gene; lacks a functional ICP47 gene; and comprises a gene encoding human GM-CSF; and (ii) a package insert or label with directions to treat stages IIIb to IV melanoma by using a combination of the herpes simplex virus and an immune checkpoint inhibitor, wherein said immune checkpoint inhibitor is an anti-PD-1 or anti-CTLA-4 antibody. 3. A method for the treatment of melanoma, said method comprising administering to a patient with stages IIIb to IV melanoma: (i) a herpes simplex virus, wherein said herpes simplex virus: lacks a functional ICP34.5 gene; lacks a functional ICP47 gene; and comprises a gene encoding human GM-CSF, and wherein said herpes simplex virus is administered by intratumoral injection at a dose of up to 4.0 ml of 10.sup.6 PFU/mL at day 1 of week 1 followed by a dose of up to 4.0 ml of 10.sup.8 PFU/mL at day 1 of week 4, and every 2 weeks thereafter until complete response; and (ii) an anti-CTLA-4 antibody, wherein said anti-CTLA-4 antibody is administered intravenously at a dose of 3 mg/kg every 3 weeks for 4 infusions beginning after the third dose of said herpes simplex virus. 4. The method according to claim 1, wherein said anti-PD-1 antibody or anti-CTLA-4 antibody is an IgG antibody. 5. The method of claim 1, wherein the anti-CTLA-4 antibody is ipilimumab. 6. The method according to claim 1 or 4, wherein the administration of the herpes simplex virus precedes the administration of the anti-PD-1 or anti-CTLA-4 antibody. 7. The method according to claim 1 or 4, wherein the herpes simplex virus is talimogene laherparepvec. 8. The method according to claim 1, wherein the anti-PD-1 antibody is selected from the group consisting of nivolumab, lambrolizumab, CT-011, and AMP-224. 9. The kit according to claim 2, wherein the directions to treat stages IIIb to IV melanoma comprise instructions to administer to a patient with stages IIIb to IV melanoma: (i) a herpes simplex virus administered by intratumoral injection into injectable cutaneous, subcutaneous, and nodal tumors at a dose of up to 4.0 ml of 10.sup.6 PFU/mL at day 1 of week 1 followed by a dose of up to 4.0 ml of 10.sup.8 PFU/mL at day 1 of week 4, and every 2 weeks thereafter until complete response; and (ii) an anti-CTLA-4 antibody administered intravenously at a dose of 3 mg/kg every 3 weeks for 4 infusions beginning after the third dose of the herpes simplex virus. 10. A method of manufacturing the kit of claim 2. 11. The method according to claim 1, wherein: said herpes simplex virus is talimogene laherparepvec; and said anti-CTLA-4 antibody is ipilimumab. 12. The method according to claim 3, wherein: said herpes simplex virus is talimogene laherparepvec; and said anti-CTLA-4 antibody is ipilimumab. 13. The method according to claim 3 or 12, wherein said herpes simplex virus is administered by intratumoral injection into injectable cutaneous, subcutaneous, and nodal tumors. 14. The kit according to claim 2 or 9, wherein said anti-PD-1 antibody or anti-CTLA-4 antibody is an IgG antibody. 15. The method according to claim 1, wherein said anti-PD-1 antibody is lambrolizumab or nivolumab. 16. The method according to claim 1, wherein: said herpes simplex virus is talimogene laherparepvec; and said anti-PD-1 antibody is lambrolizumab or nivolumab. 17. The kit according to claim 2, wherein said anti-PD-1 antibody is lambrolizumab or nivolumab. 18. The kit according to claim 2, wherein: said herpes simplex virus is talimogene laherparepvec; and said anti-PD-1 antibody is lambrolizumab or nivolumab. 19. The kit according to claim 2, wherein: said herpes simplex virus is talimogene laherparepvec; and said anti-CTLA-4 antibody is ipilimumab.

Details for Patent 10,034,938

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	March 25, 2011	10,034,938	2033-08-30
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	October 27, 2015	10,034,938	2033-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	December 22, 2014	10,034,938	2033-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	October 04, 2017	10,034,938	2033-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	August 27, 2021	10,034,938	2033-08-30

International Patent Family for US Patent 10,034,938

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014036412
United States of America	2019060452
United States of America	2015202290
Portugal	3381942
South Korea	20210008155