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Last Updated: September 22, 2021

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Claims for Patent: 10,081,681

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Summary for Patent: 10,081,681
Title:Combination of anti-LAG-3 antibodies and anti-PD-1 antibodies to treat tumors
Abstract: Provided are methods for clinical treatment of tumors (e.g., advanced solid tumors) using an anti-LAG-3 antibody in combination with an anti-PD-1 antibody.
Inventor(s): Korman; Alan J. (Piedmont, CA), Lonberg; Nils (Woodside, CA), Fontana; David J. (Clyde Hill, WA), Gutierrez; Andres A. (Lawrenceville, NJ), Selby; Mark J. (San Francisco, CA), Lewis; Katherine E. (Lake Forest Park, WA)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:15/021,102
Patent Claims:1. A method of treating melanoma in a human patient, the method comprising administering to the patient an effective amount of each of: (a) an anti-LAG-3 antibody comprising CDR1, CDR2 and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO:3, and CDR1, CDR2 and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:5, (b) an anti-PD-1 antibody comprising CDR1, CDR2 and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO: 19, and CDR1, CDR2 and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:21, wherein the method comprises at least one administration cycle, wherein the cycle is a period of two weeks, wherein for each of the at least one cycle, one dose of the anti-LAG-3 antibody is administered at a dose of 80 mg and one dose of the anti-PD-1 antibody is administered at a dose of 240 mg, and wherein the patient has been previously treated with anti-PD-1 or anti-PD-L1 antibody therapy.

2. The method of claim 1, further comprising the administration of an anti-CTLA-4 antibody.

3. The method of claim 1, wherein the anti-PD-1 and anti-LAG-3 antibodies are formulated for intravenous administration.

4. The method of claim 1, wherein the anti-PD-1 and anti-LAG-3 antibodies are formulated together.

5. The method of claim 1, wherein the anti-PD-1 and anti-LAG-3 antibodies are formulated separately.

6. The method of claim 1, wherein the treatment consists of up to 12 cycles.

7. The method of claim 1, wherein the anti-PD-1 antibody is administered prior to administration of the anti-LAG-3 antibody.

8. The method of claim 1, wherein the anti-PD-1 antibody is administered after administration of the anti-LAG-3 antibody.

9. The method of claim 1, wherein the anti-PD-1 antibody is administered concurrently with the anti-LAG-3 antibody.

10. The method of claim 1, wherein the anti-LAG-3 antibody comprises (a) a heavy chain variable region CDR1 comprising the sequence set forth in SEQ ID NO:7; (b) a heavy chain variable region CDR2 comprising the sequence set forth in SEQ ID NO:8; (c) a heavy chain variable region CDR3 comprising the sequence set forth in SEQ ID NO:9; (d) a light chain variable region CDR1 comprising the sequence set forth in SEQ ID NO:10; (e) a light chain variable region CDR2 comprising the sequence set forth in SEQ ID NO:11; and (f) a light chain variable region CDR3 comprising the sequence set forth in SEQ ID NO:12.

11. The method of claim 1, wherein the anti-LAG-3 antibody comprises heavy and light chain variable regions comprising the sequences set forth in SEQ ID NOs:3 and 5, respectively.

12. The method of claim 1, wherein the anti-LAG-3 antibody comprises heavy and light chains comprising the sequences set forth in SEQ ID NOs: 1 and 2, respectively.

13. The method of claim 1, wherein the anti-PD-1 antibody comprises (a) a heavy chain variable region CDR1 comprising the sequence set forth in SEQ ID NO:23; (b) a heavy chain variable region CDR2 comprising the sequence set forth in SEQ ID NO:24; (c) a heavy chain variable region CDR3 comprising the sequence set forth in SEQ ID NO:25; (d) a light chain variable region CDR1 comprising the sequence set forth in SEQ ID NO:26; (e) a light chain variable region CDR2 comprising the sequence set forth in SEQ ID NO:27; and (f) a light chain variable region CDR3 comprising the sequence set forth in SEQ ID NO:28.

14. The method of claim 1, wherein the anti-PD-1 antibody comprises heavy and light chain variable regions comprising the sequences set forth in SEQ ID NOs: 19 and 21, respectively.

15. The method of claim 1, wherein the anti-PD-1 antibody comprises heavy and light chains comprising the sequences as set forth in SEQ ID NOs: 17 and 18, respectively.

16. The method of claim 1, wherein the anti-LAG-3 antibody and/or anti-PD-1 antibody is a full-length antibody.

17. A kit for treating melanoma in a human patient, the kit comprising: (a) a dose of an anti-LAG-3 antibody comprising CDR1, CDR2 and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO:3, and CDR1, CDR2 and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:5; (b) a dose of an anti-PD-1 antibody comprising CDR1, CDR2 and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO: 19, and CDR1, CDR2 and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:21; and (c) instructions for using the anti-LAG-3 antibody and anti-PD-1 antibody in the method of claim 1.

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

Summary for Patent: ⤷  Free Forever Trial

PCT Information
PCT FiledSeptember 18, 2014PCT Application Number:PCT/US2014/056277
PCT Publication Date:March 26, 2015PCT Publication Number:WO2015/042246

Details for Patent 10,081,681

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Bristol Myers Squibb YERVOY ipilimumab INJECTABLE; INJECTION 125377 001 2011-03-25 ⤷  Free Forever Trial Bristol-Myers Squibb Company (Princeton, NJ) 2033-09-20 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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