TREATMENT OF HODGKIN'S LYMPHOMA USING AN ANTI-PD-1 ANTIBODY

• US 20160347836A1
• Filed: 05/26/2016
• Published: 12/01/2016
• Est. Priority Date: 05/28/2015
• Status: Abandoned Application

• Current Assignee: Bristol-Myers Squibb Company
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Grosso, Joseph
• Application Number:
  US15/164,960
• Publication Number:
  US 20160347836A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/507 Comprising a combination of two or more separate antibodies
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: C07K 16/2803 against the immunoglobulin superfamily
• CPC Class Codes: C07K 16/2818 against CD28 or CD152
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 2333/4704 Inhibitors; Supressors
• CPC Class Codes: G01N 33/57407 Specifically defined cancers

Abstract

This disclosure provides methods for treating Hodgkin'"'"'s lymphoma in a subject comprising administering to the subject an anti-Programmed Death-1 (PD-1) antibody. In some embodiments, this invention relates to methods for treating Hodgkin'"'"'s lymphoma in a subject comprising administering to the subject a combination of an anti-cancer agent which is an anti-Programmed Death-1 (PD-1) antibody and another anti-cancer agent such as an anti-Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4) antibody.

Claims

1. A method for treating a subject afflicted with a Hodgkin'"'"'s lymphoma comprising administering to the subject a therapeutically effective amount of an antibody or an antigen-binding portion thereof that binds specifically to a Programmed Death-1 receptor (PD-1).

2. The method of claim 1, wherein the Hodgkin'"'"'s lymphoma expresses PD-L1 and/or PD-L2.

3. The method of claim 2, wherein the PD-L1 and/or PD-L2 expression is at least about 1%.

4. A method for identifying a subject afflicted with a tumor derived from a Hodgkin'"'"'s lymphoma who is suitable for an anti-PD1 antibody therapy comprising measuring PD-L1 and/or PD-L2 expression on the tumor, wherein the tumor has a PD-L1 and/or PD-L2 expression of at least about 1% and wherein the subject is administered a therapeutically effective amount of an anti-PD-1 antibody or antigen-binding portion thereof.

5. The method of claim 4, wherein the PD-L1 and/or PD-L2 expression of the tumor is at least about 5%.

6. The method of any claim 4, wherein the PD-L1 and/or PD-L1 expression of the tumor is at least about 10%.

7. The method of claim 4, wherein the anti-PD-1 antibody or antigen-binding portion thereof cross-competes with nivolumab for binding to human PD-1.

8. The method of claim 7, wherein the anti-PD-1 antibody or antigen-binding portion thereof is a chimeric, humanized or human monoclonal antibody or a portion thereof.

9. The method of claim 8, wherein the anti-PD-1 antibody or antigen-binding portion thereof comprises a heavy chain constant region which is of a human IgG1 or IgG4 isotype.

10. The method of claim 9, wherein the anti-PD-1 antibody is nivolumab.

11. The method of claim 9, wherein the anti-PD-1 antibody is pembrolizumab.

12. The method of claim 9, which further comprises administering one or more additional anti-cancer agent.

13. The method of claim 12, wherein the anti-cancer agent is selected from the group consisting of an antibody or antigen-binding portion thereof that binds specifically to a CTLA-4 and inhibits CTLA-4 activity, a chemotherapy, a platinum-based doublet chemotherapy or a tyrosine kinase inhibitor.

14. The method of claim 12, wherein the anti-cancer agent is an antibody or antigen-binding portion thereof that binds specifically to a CTLA-4 and inhibits CTLA-4 activity.

15. The method of claim 9, wherein the PD-L1 and/or PD-L2 expression is measured by automated immunohistochemistry (IHC) or fluorescent in situ hybridization.

16. A kit for treating a subject afflicted with a tumor derived from a Hodgkin'"'"'s lymphoma, the kit comprising:

(a) an anti-PD-1 antibody or antigen-binding portion thereof;

(b) instructions for determining the PD-L1 and/or PD-L2 expression of the tumor and, if the tumor expresses PD-L1 or PD-L2, administering the anti-PD-1 antibody or antigen-binding portion thereof to the subject in the methods of claim 15.

17. The kit of claim 16, further comprising an agent to determine the PD-L1 and/or PD-L2 expression of the tumor.

18. The kit of claim 17, wherein the PD-L1 and/or PD-L2 expression is measured by an anti-PD-L1 and/or PD-L2 antibody or antigen-binding portion thereof.