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	03/25/2011		2032-08-30
Amgen, Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10/27/2015		2032-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	12/22/2014		2032-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10/04/2017		2032-08-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	08/27/2021		2032-08-30