Claims for Patent: 7,306,801

Summary for Patent: 7,306,801

Title:	Methods of therapy for cancers characterized by overexpression of the HER2 receptor protein
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.
Inventor(s):	Caligiuri; Michael A. (Columbus, OH), Meropol; Neal J. (Jenkintown, PA), Schilsky; Richard L. (LaGrange, IL)
Assignee:	Health Research, Inc. (Buffalo, NY) ARCH Development (Chicago, IL)
Application Number:	09/855,342
Patent Claims:	1. A method of treating a subject for a breast cancer characterized by overexpression of the HER2 receptor protein, said method comprising concurrent therapy with the recombinant, humanized anti-HER2 antibody Trastuzumab and the recombinant des-alanyl-1, serine-125 human interleukin-2 molecule Aldesleukin, wherein said concurrent therapy comprises administering to said subject at least one therapeutically effective dose of said Aldesleukin in combination with a dosing regimen for said Trastuzumab, wherein said dosing regimen for said Trastuzumab comprises administering to said subject at least one therapeutically effective dose of said Trastuzumab, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 1.0 mg/kg to about 10.0 mg/kg and wherein said therapeutically effective dose of said Aldesleukin is in the range from about 0.5 MIU/m2 to about 4.0 MIU/m2. 2. The method of claim 1, wherein said therapeutically effective dose of said Aldesleukin is administered as a pharmaceutical composition selected from the group consisting of a monomeric Aldesleukin pharmaceutical composition, a multimeric Aldesleukin pharmaceutical composition, a lyophilized Aldesleukin pharmaceutical composition, and a spray-dried Aldesleukin pharmaceutical composition. 3. The method of claim 1, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 2.0 mg/kg to about 9.0 mg/kg and wherein said therapeutically effective dose of said Aldesleukin is in the range from about 0.6 MIU/m2 to about 3.0 MIU/m2. 4. The method of claim 3, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 3.0 mg/kg to about 8.0 mg/kg and wherein said therapeutically effective dose of said Aldesleukin is in the range from about 0.8 MIU/m2 to about 1.5 MIU/m2. 5. The method of claim 4, wherein said therapeutically effective dose of said Trastuzumab is about 4.0 mg/kg and wherein said therapeutically, effective dose of said Aldesleukin is about 1.0 MIU/m2. 6. A method of treating a subject for a breast cancer characterized by overexpression of the HER2 receptor protein, said method comprising concurrent therapy with the recombinant, humanized anti-HER2 antibody Trastuzumab and a native human IL-2 polypeptide, wherein said concurrent therapy comprises administering to said subject at least one therapeutically effective dose of said IL-2 polypeptide in combination with a dosing regimen for said Trastuzumab, wherein said dosing regimen for said Trastuzumab comprises administering to said subject at least one therapeutically effective dose of said Trastuzumab, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 1.0 mg/kg to about 10.0 mg/kg and wherein said therapeutically effective dose of said IL-2 polypeptide is in the range from about 0.5 MIU/m2 to about 4.0 MIU/m2. 7. The method of claim 6, wherein said therapeutically effective dose of said IL-2 polypeptide is administered as a pharmaceutical composition selected from the group consisting of a monomeric IL-2 pharmaceutical composition, a multimeric IL-2 pharmaceutical composition, a lyophilized IL-2 pharmaceutical composition, and a spray-dried IL-2 pharmaceutical composition. 8. The method of claim 6, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 2.0 mg/kg to about 9.0 mg/kg and wherein said therapeutically effective dose of said IL-2 polypeptide is in the range from about 0.6 MIU/m2 to about 3.0 MIU/m2. 9. The method of claim 8, wherein said therapeutically effective dose of said Trastuzumab is in the range from about 3.0 mg/kg to about 8.0 mg/kg and wherein said therapeutically effective dose of said IL2 polypeptide is in the range from about 0.8 MIU/m2 to about 1.5 MIU/m2. 10. The method of claim 9, wherein said therapeutically effective dose of said Trastuzumab is about 4.0 mg/kg and wherein said therapeutically effective dose of said IL-2 polypeptide is about 1.0 MIU/m2.

Details for Patent 7,306,801

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992		2020-05-15
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2020-05-15
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2020-05-15
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2020-05-15