Claims for Patent: 10,457,725

Summary for Patent: 10,457,725

Title:	Methods of treating skin cancer by administering a PD-1 inhibitor
Abstract:	The present invention provides methods for treating, reducing the severity, or inhibiting the growth of cancer (e.g., skin cancer). The methods of the present invention comprise administering to a subject in need thereof a therapeutically effective amount of a programmed death 1 (PD-1) antagonist (e.g., an anti-PD-1 antibody). In certain embodiments, the skin cancer is cutaneous squamous cell carcinoma or basal cell carcinoma.
Inventor(s):	Fury; Matthew G. (New York, NY), Lowy; Israel (Dobbs Ferry, NY)
Assignee:	Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	15/593,915
Patent Claims:	1. A method of treating or inhibiting the growth of a tumor comprising: (a) selecting a patient with cutaneous squamous cell carcinoma (CSCC); and (b) administering to the patient a therapeutically effective amount of an antibody or antigen-binding fragment thereof that specifically binds PD-1, wherein the therapeutically effective amount is administered once every two weeks in a dose comprising 1 to 3 mg/kg of the patient's body weight; wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2 and HCDR3) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and three light chain complementarity determining regions (LCDR1, LCDR2 and LCDR3) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 2. 2. The method of claim 1, wherein the anti-PD-1 antibody or antigen-binding fragment thereof is administered as a monotherapy. 3. The method of claim 1, wherein the CSCC is metastatic, unresectable and/or locally advanced. 4. The method of claim 3, wherein the patient is intolerant to or the CSCC progresses after prior treatment with an anti-cancer therapy. 5. The method of claim 1, wherein the CSCC is metastatic CSCC, and wherein said patient has been treated with at least one prior anti-cancer therapy selected from the group consisting of surgery, radiation, chemotherapy, and another anti-PD-1 antibody. 6. The method of claim 1, wherein the CSCC is locally advanced CSCC, and wherein said patient is not amenable to curative surgery. 7. The method of claim 1, wherein each dose comprises 1 or 3 mg/kg of the patient's body weight. 8. The method of claim 7, wherein each dose comprises 3 mg/kg of the patient's body weight. 9. The method of claim 1, wherein the patient is resistant or inadequately responsive to, or relapsed after prior therapy. 10. The method of claim 1, wherein the administration leads to at least one effect selected from the group consisting of inhibition of tumor growth, tumor regression, reduction in the size of a tumor, reduction in tumor cell number, delay in tumor growth, abscopal effect, inhibition of tumor metastasis, reduction in metastatic lesions over time, reduced use of chemotherapeutic or cytotoxic agents, reduction in tumor burden, increase in progression-free survival, increase in overall survival, complete response, partial response, and stable disease. 11. The method of claim 1, further comprising administering to the patient an additional therapeutic agent or therapy, wherein the additional therapeutic agent or therapy is selected from the group consisting of surgery, radiation, a chemotherapeutic agent, a cancer vaccine, a programmed death ligand 1 (PD-L1) inhibitor, a lymphocyte activation gene 3 (LAG3) inhibitor, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, a T-cell immunoglobulin and mucin-domain containing-3 (TIM3) inhibitor, a B- and T-lymphocyte attenuator (BTLA) inhibitor, a T cell immunoreceptor with Ig and ITIM domains (TIGIT) inhibitor, a CD47 inhibitor, an indoleamine-2,3-dioxygenase (IDO) inhibitor, a bispecific anti-CD3/anti-CD20 antibody, a vascular endothelial growth factor (VEGF) antagonist, an angiopoietin-2 (Ang2) inhibitor, a transforming growth factor beta (TGF.beta.) inhibitor, a CD38 inhibitor, an epidermal growth factor receptor (EGFR) inhibitor, granulocyte-macrophage colony-stimulating factor (GM-CSF), cyclophosphamide, an antibody to a tumor-specific antigen, Bacillus Calmette-Guerin vaccine, a cytotoxin, an interleukin 6 receptor (IL-6R) inhibitor, an interleukin 4 receptor (IL-4R) inhibitor, an IL-10 inhibitor, IL-2, IL-7, IL-21, IL-15, an antibody-drug conjugate, an anti-inflammatory drug, and a dietary supplement. 12. The method of claim 1, wherein the anti-PD-1 antibody or antigen-binding fragment thereof is administered intravenously, subcutaneously, or intraperitoneally. 13. The method of claim 1, wherein HCDR1 comprises the amino acid sequence of SEQ ID NO: 3; HCDR2 comprises the amino acid sequence of SEQ ID NO: 4; HCDR3 comprises the amino acid sequence of SEQ ID NO: 5; LCDR1 comprises the amino acid sequence of SEQ ID NO: 6; LCDR2 comprises the amino acid sequence of SEQ ID NO: 7; and LCDR3 comprises the amino acid sequence of SEQ ID NO: 8. 14. The method of claim 1, wherein the HCVR comprises the amino acid sequence of SEQ ID NO: 1 and the LCVR comprises the amino acid sequence of SEQ ID NO: 2. 15. The method of claim 1, wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises a HCVR with 90% sequence identity to SEQ ID NO: 1. 16. The method of claim 1, wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises a LCVR with 90% sequence identity to SEQ ID NO: 2. 17. The method of claim 1, wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises a HCVR with 90% sequence identity to SEQ ID NO: 1 and a LCVR with 90% sequence identity to SEQ ID NO: 2. 18. The method of claim 1, wherein the anti-PD-1 antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9 and a light chain comprising the amino acid sequence of SEQ ID NO: 10.

Details for Patent 10,457,725

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2036-05-13