Treatment method
AssigneeHoffmann-La Roche Inc.
InventorsMarina BACAC, Stefan EVERS, Christian KLEIN, Pavel PISA, Eva ROSSMANN, Jose SARO, Pablo UMANA
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Abstract
The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent. The invention further relates to methods of treating a disease, particularly a B-cell proliferative disorder, and methods for reduction of adverse effects in response to the administration of a therapeutic agent, particularly a T-cell activating therapeutic agent.
Claims23
A Type II anti-CD20 antibody for use in a method of treating a disease in a subject, the method comprising a treatment regimen comprising
- (i) administration to the subject of the Type II anti-CD20 antibody,
- and consecutively after a period of time
- (ii) administration to the subject of a therapeutic agent,
- wherein the period of time between the administration of the Type II anti-CD20 antibody and the administration of the therapeutic agent is sufficient for reduction of the number of B-cells in the subject in response to the administration of the Type II anti-CD20 antibody.
A Type II anti-CD20 antibody for use in a method for (i) reducing the formation of anti-drug antibodies (ADAs) against a therapeutic agent in a subject and/or (ii) reducing cytokine release associated with the administration a therapeutic agent, particularly a T-cell activating therapeutic agent, in a subject, comprising administration of the Type II anti-CD20 antibody to the subject prior to administration of the therapeutic agent.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody comprises a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO:
- 4, the HCDR2 of SEQ ID NO:
- 5, and the HCDR3 of SEQ ID NO:
- 6;
- and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO:
- 7, the LCDR2 of SEQ ID NO:
- 8 and the LCDR3 of SEQ ID NO:
- 9.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody comprises the heavy chain variable region sequence of SEQ ID NO:
- 10 and the light chain variable region sequence of SEQ ID NO:
- 11.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody is an IgG antibody, particularly an IgG1 antibody, and wherein at least about 40% of the N-linked oligosaccharides in the Fc region of the anti-CD20 antibody are non-fucosylated.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody is obinutuzumab.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises a polypeptide.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises an antibody.
The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises a cytokine, particularly interleukin-2.
Dependencies are inferred from the claim text.