Bispecific antibodies against CD3 and CD20

Patent metadata

Field	Value
Publication number	US-12435154-B2
Application number	US-202117314946-A
Country	US
Kind code	B2
Filing date	May 7, 2021
Priority date	May 8, 2020
Publication date	Oct 7, 2025
Grant date	Oct 7, 2025

Abstract

The present invention relates to bispecific antibodies (bsAbs) and the use of such antibodies in the treatment of disease in subjects. Moreover, advantageous treatment regimens are provided for the treatment of B-cell Non-Hodgkin Lymphoma (B-NHL).

First claim

The invention claimed is:

1. A method of treating a B-cell non-Hodgkin lymphoma (B-NHL) in a human subject, the method comprising subcutaneously administering a dose of 0.16 mg of epcoritamab to the subject on day one (1) of treatment and subcutaneously administering a dose of 0.8 mg of epcoritamab to the subject on day eight (8) of treatment,
wherein the subject does not experience cytokine release syndrome (CRS) or experiences manageable cytokine release syndrome of grade 1 or grade 2, and
wherein after day eight (8) of treatment epcoritamab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs.

2. The method of claim 1 , wherein 48 mg of epcoritamab is administered subcutaneously to the human subject on days 15 and 22 of treatment.

3. The method of claim 2 , wherein said B-NHL is selected from the group consisting of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL), and wherein the patient achieves a complete response (CR).

4. The method of claim 3 , wherein said B-NHL is diffuse large B-cell lymphoma (DLBCL).

5. The method of claim 3 , wherein said B-NHL is mantle cell lymphoma (MCL).

6. The method of claim 3 , wherein said B-NHL is follicular lymphoma (FL).

7. The method of claim 3 , wherein said B-NHL is marginal-zone lymphoma (MZL).

8. The method of claim 3 , wherein said B-NHL is small lymphocytic lymphoma (SLL).

9. The method of claim 3 , wherein said B-NHL is relapsed or refractory B-NHL.

10. The method of claim 3 , wherein said B-NHL is chronic lymphocytic lymphoma (CLL).

11. The method of claim 1 , wherein 24 mg of epcoritamab is administered subcutaneously to the human subject on days 15 and 22 of treatment.

12. The method of claim 11 , wherein said B-NHL is selected from the group consisting of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL), and wherein the patient achieves a complete response (CR).

13. The method of claim 11 , wherein said B-NHL is diffuse large B-cell lymphoma (DLBCL).

14. The method of claim 11 , wherein said B-NHL is mantle cell lymphoma (MCL).

15. The method of claim 11 , wherein said B-NHL is follicular lymphoma (FL).

16. The method of claim 11 , wherein said B-NHL is marginal-zone lymphoma (MZL).

17. The method of claim 11 , wherein said B-NHL is small lymphocytic lymphoma (SLL).

18. The method of claim 11 , wherein said B-NHL is relapsed or refractory B-NHL.

19. The method of claim 11 , wherein said B-NHL is chronic lymphocytic lymphoma (CLL).

20. The method of claim 1 , wherein said B-NHL is selected from the group consisting of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL).

21. The method of claim 20 , wherein said B-NHL is diffuse large B-cell lymphoma (DLBCL).

22. The method of claim 20 , wherein said B-NHL is mantle cell lymphoma (MCL).

23. The method of claim 20 , wherein said B-NHL is follicular lymphoma (FL).

24. The method of claim 20 , wherein said B-NHL is marginal-zone lymphoma (MZL).

25. The method of claim 20 , wherein said B-NHL is small lymphocytic lymphoma (SLL).

26. The method of claim 20 , wherein said B-NHL is relapsed or refractory B-NHL.

27. The method of claim 20 , wherein said B-NHL is chronic lymphocytic lymphoma (CLL).

28. The method of claim 1 , wherein prior to the day 1 of treatment with epcoritamab the human subject has received at least one prior line of treatment for the B-NHL.

29. The method of claim 1 , wherein prior to the day 1 of treatment with epcoritamab the human subject has received at least two prior lines of treatment for the B-NHL.

Assignees

• Genmab As

Inventors

• Ahmadi Tahamtan
• Gupta Manish
• Li Tommy
• Oliveri Roberto
• Demarco Dena
• Hiemstra Ida
• Chiu Christopher
• Elliott Brian
• Azaryan Ada

Classifications

• A61K39/00

  Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53) · CPC title

• C07K2317/31

  multispecific · CPC title

• C07K2317/24

  containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered · CPC title

• C07K2317/21

  from primates, e.g. man · CPC title

• C07K16/2809 Primary

  against the T-cell receptor (TcR)-CD3 complex · CPC title