Claims for Patent: 10,144,772

Summary for Patent: 10,144,772

Title:	Method for treating melanoma
Abstract:	The present invention relates to a TNF.alpha. blocking agent for use in the treatment and prevention of melanoma in a subject in whom melanoma cells express MHCI and in whom stroma cells exhibit TNF expression.
Inventor(s):	Segui; Bruno (Toulouse, FR), Andrieu-Abadie; Nathalie (Toulouse, FR), Levade; Thierry (Toulouse, FR), Colacios Viatge; Celine (Toulouse, FR), Rochaix; Philippe (Toulouse, FR), Bertrand; Florie (Toulouse, FR), Benoist; Herve (Toulouse, FR), Rochotte; Julia (Toulouse, FR)
Assignee:	INSERM (Institut National de la Sante et de la Recherche Medicale) (Paris, FR) Centre Hospitalier Universitaire de Toulouse (Toulouse, FR) Institut Claudius Regaud (Toulouse, FR) Universite Paul Sabatier Toulouse III (Toulouse, FR)
Application Number:	15/310,158
Patent Claims:	1. A method of treating melanoma in a subject in need thereof, comprising identifying an immunocompetent subject, wherein immunocompetency is determined by finding in a tumor sample from the subject: CD8.sup.+ tumor infiltrating lymphocytes (TIL), a high endothelial venule (HEV) MECA79+ differentiation or density, melanoma cells that express Major Histocompatibility Complex Class I (MHCI), and stroma cells in contact with the melanoma cells that express tumor necrosis factor-alpha (TNF.alpha.) ; wherein an expression level of MHCI in melanoma cells in the tumor sample from the subject is higher than a predetermined reference value, and an expression level of TNF.alpha. in stroma cells in contact with the melanoma cells in the tumor sample from the subject is higher than a predetermined reference value, and administering to the subject a therapeutically effective amount of TNF.alpha. blocking agent. 2. A method for treating melanoma comprising the steps of i) determining that CD8.sup.+ tumor infiltrating lymphocytes (TIL) and a high endothelial venule (HEV) MECA79+ differentiation or density are present in a melanoma tumor sample obtained from a subject, wherein an expression level of Major Histocompatibility Complex Class I (MHCI) in melanoma cells in the sample obtained from the subject is higher than a predetermined reference value and determining that an expression level of tumor necrosis factor-alpha (TNF.alpha.) in stroma cells in contact with the melanoma cells in the sample obtained from the subject is higher than a predetermined reference value, and ii) administering to the subject a therapeutically effective amount of a TNF.alpha. blocking agent. 3. The method of claim 1, wherein the TNF.alpha. blocking agent is etanercept. 4. The method of claim 1, wherein the TNF.alpha. blocking agent is a monoclonal antibody. 5. The method of claim 4, wherein the monoclonal antibody is infliximab or adalimumab. 6. The method of claim 1, wherein the TNF.alpha. blocking agent is a TNF-R1 antagonist. 7. The method of claim 2, wherein the TNF.alpha. blocking agent is etanercept. 8. The method of claim 2, wherein the TNF.alpha. blocking agent is a monoclonal antibody. 9. The method of claim 8, wherein the monoclonal antibody is infliximab or adalimumab. 10. The method of claim 2, wherein the TNF.alpha. blocking agent is a TNF-R1 antagonist. 11. A method of treating or inhibiting growth or metastasis of melanoma in a subject in whom melanoma cells express Major Histocompatibility Complex Class I (MHCI) and in whom stroma cells exhibit tumor necrosis factor-alpha (TNF.alpha.) expression comprising administering to the subject a therapeutically effective amount of an anti-TNF-R1 agent when CD8.sup.+ tumor infiltrating lymphocytes (TIL) and a high endothelial venule (HEV) MECA79+ differentiation or density are present in a melanoma tumor sample obtained from the subject, and an expression level of MHCI in melanoma cells in a sample from the subject is higher than a predetermined reference value, and an expression level of TNF.alpha. in stroma cells in a sample from the subject is higher than a predetermined reference value. 12. A method for treating melanoma in a subject comprising the steps of i) identifying a subject having an infiltration of CD8+ TIL in a melanoma tumor having a high endothelial venule (HEV) MECA79+ differentiation or density within the melanoma tumor, ii) determining an expression level of Major Histocompatibility Complex Class I (MHCI) in melanoma cells in a sample obtained from the subject and determining an expression level of tumor necrosis factor-alpha (TNF.alpha.) in stroma cells in a sample obtained from the subject, iii) comparing expression levels determined at step ii) with predetermined reference values and iv) administering to the subject a therapeutically effective amount of an anti-TNF-R1 agent when the expression levels determined at step ii) are higher than the predetermined reference value.

Details for Patent 10,144,772

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2034-05-12
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2034-05-12
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2034-05-12