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Last Updated: March 28, 2024

Claims for Patent: 10,174,113


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Summary for Patent: 10,174,113
Title:Treatment of PD-L1-negative melanoma using an anti-PD-1 antibody and an anti-CTLA-4 antibody
Abstract: The invention provides a method of treating a melanoma comprising (i) identifying a patient having a PD-L1-negative melanoma and (ii) administering to the patient a combination of an anti-PD-1 antibody or an antigen-binding portion thereof and an anti-CTLA-4 antibody or an antigen-binding portion thereof. The methods of the invention can extend progression-free survival for over 8 months and/or reduces the tumor size at least about 10%, about 20%, about 30%, about 40%, or about 50% compared to the tumor size prior to the administration.
Inventor(s): Yang; Arvin (Princeton, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:15/141,769
Patent Claims:1. A method for treating a melanoma tumor in a human patient in need thereof comprising: (i) identifying a patient having a PD-L1-negative melanoma tumor; and (ii) administering to the patient: (a) about 1 mg/kg of an antibody or an antigen-binding portion thereof that binds specifically to a human PD-1 ("an anti-PD-1 antibody") and a dose of an antibody or an antigen-binding portion thereof that binds specifically to a human CTLA-4 ("an anti-CTLA-4 antibody") every three weeks for about 4 doses; followed by (b) a dose of the anti-PD-1 antibody, wherein the dose in (b) is a flat dose of about 240 mg or about 480 mg.

2. A method for treating a melanoma tumor in a human patient in need thereof comprising administering to the patient: (a) about 1 mg/kg of an antibody or an antigen-binding portion thereof that binds specifically to a human PD-1 ("an anti-PD-1 antibody") and a dose of an antibody or an antigen-binding portion thereof that binds specifically to a human CTLA-4 ("an anti-CTLA-4 antibody") every three weeks for about 4 doses; followed by (b) a dose of the anti-PD-1 antibody, wherein the dose in (b) is a flat dose of about 240 mg or about 480 mg.

3. The method of claim 2, wherein the patient is characterized by (i) extended progression-free survival for over 8 months following the administration, (ii) tumor size reduction at least about 10% compared to the tumor size prior to the administration, or (iii) both (i) and (ii).

4. The method of claim 2, further comprising measuring a PD-L1 expression on the melanoma tumor prior to the administration.

5. The method of claim 4, wherein the measuring comprises providing a test tissue sample obtained from the patient, the test tissue sample comprising tumor cells and/or tumor-infiltrating inflammatory cells.

6. The method of claim 5, wherein the measuring further comprises assessing the proportion of cells in the test tissue sample that express PD-L1 on the cell surface.

7. The method of claim 6, wherein the test tissue sample is a formalin-fixed paraffin-embedded (FFPE) tissue sample, and wherein the presence of PD-L1 is determined using an automated IHC assay.

8. The method of claim 7, wherein the IHC assay is performed using an anti-PD-L1 monoclonal antibody that specifically binds to the PD-L1 and wherein the anti-PD-L1 monoclonal antibody comprises a variable heavy region comprising the amino acid sequence set forth in SEQ ID NO: 1 and a variable light region comprising the amino acid sequence set forth in SEQ ID NO: 2.

9. The method of claim 2, wherein less than about 5% of tumor cells show binding to an anti-PD-L1 antibody or an antigen-binding portion thereof.

10. The method of claim 2, wherein the anti-PD-1 antibody is nivolumab.

11. The method of claim 2, wherein the dose of the anti-PD-1 antibody in (b) is about 240 mg administered once every two weeks.

12. The method of claim 2, wherein the dose of the anti-PD-1 antibody in (b) is about 480 mg administered once every four weeks.

13. The method of claim 2, wherein the anti-CTLA-4 antibody is ipilimumab.

14. The method of claim 2, wherein the dose of the anti-CTLA-4 antibody is from 0.1 mg/kg to 10.0 mg/kg.

15. The method of claim 14, wherein the dose of the anti-CTLA-4 antibody is 3 mg/kg.

16. The method of claim 2, further comprising administering an anti-cancer agent.

17. The method of claim 1, wherein the dose of the anti-PD-1 antibody in (b) is about 240 mg administered once every two weeks.

18. The method of claim 1, wherein the dose of the anti-PD-1 antibody in (b) is about 480 mg administered once every four weeks.

19. The method of claim 1, wherein the dose of the anti-CTLA-4 antibody is 3 mg/kg.

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

Details for Patent 10,174,113

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company YERVOY ipilimumab Injection 125377 03/25/2011 ⤷  Try a Trial 2035-04-28
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 12/22/2014 ⤷  Try a Trial 2035-04-28
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 10/04/2017 ⤷  Try a Trial 2035-04-28
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 08/27/2021 ⤷  Try a Trial 2035-04-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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