Methods of therapy for cancers characterized by overexpression of the HER2 receptor protein

a cancer and receptor protein technology, applied in the field of cell proliferative disorders, can solve the problems of affecting the treatment effect of patients, affecting the treatment effect, and imposing a great limitation on the use of monoclonal antibodies, so as to promote a positive therapeutic response and promote a positive therapeutic

US20080159981A1Inactive Publication Date: 2008-07-03NOVARTIS VACCINES & DIAGNOSTICS INC
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Patent Information

Authority / Receiving Office
US · United States
Patent Type
Applications(United States)
Current Assignee / Owner
Publication Date
2008-07-03
Estimated Expiration
Not applicable · inactive patent

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Abstract

Methods for treating a subject with a cancer that is characterized by overexpression of HER2 receptor protein using a combination of interleukin-2 (IL-2) or variant thereof and at least one anti-HER2 antibody or fragment thereof are provided. These anti-tumor agents are administered as two separate pharmaceutical compositions, one containing IL-2 (or variant thereof), the other containing at least one anti-HER2 antibody (or fragment thereof), according to a dosing regimen. Administering of these two agents together potentiates the effectiveness of the anti-HER2 antibody alone, resulting in a positive therapeutic response that is improved with respect to that observed with this anti-tumor agent.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation application of U.S. patent application Ser. No. 09 / 855,342, filed May 14, 2001 from which priority is claimed pursuant to 35 U.S.C. §120, which claims the benefit under 35 U.S.C. § 119(e)(1) of U.S. Provisional Application No. 60 / 204,284, filed May 15, 2000, which applications are hereby incorporated by reference in their entireties.FIELD OF THE INVENTION

[0002] The present invention is directed to methods of therapy for cell proliferative disorders, more particularly to concurrent therapy with interleukin-2 and monoclonal antibodies targeting the HER2 receptor protein to treat cancers characterized by overexpression of the HER2 receptor protein.BACKGROUND OF THE INVENTION

[0003] Cancer research has shown an increasing interest in the use of monoclonal antibodies as a therapeutic. Raised in a similar fashion to diagnostic antibodies, therapeutic antibodies are aimed at specifically targeting tumor cells. The...

Examples

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Initial Pilot Study

Background

[0062]Interleukin-2 (IL-2) was the first biologic agent approved by the U.S. Food and Drug Administration for the treatment of patients with cancer. The initial clinical development of IL-2 involved high-dose therapy with substantial toxicity, which has limited the widespread acceptance of IL-2 in clinical practice. The anti-tumor effect in vitro of IL-2 is mediated primarily by activated natural killer (NK) cells, but the mechanism in vivo remains poorly understood. Recent descriptions of the IL-2 receptor complex, and the functional consequences of receptor-ligand interactions, have raised the possibility that more effective and less toxic methods of treatment with IL-2 are possible.

[0063]The IL-2 receptor complex has three known components. The alpha chain binds IL-2 with low affinity and does not by itself transmit an intracellular signal. The beta and gamma chains associate non-covalently to form an intermediate affinity IL-2 receptor. A high affini...