Detection of ErbB2 gene amplification to increase the likelihood of the effectiveness of ErbB2 antibody breast cancer therapy

• US 7,993,834 B2
• Filed: 11/19/2007
• Issued: 08/09/2011
• Est. Priority Date: 05/19/2000
• Status: Expired due to Fees

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Mass, Robert D.
• Primary Examiner(s): Goddard; Laura B
• Application Number:
  US11/942,449
• Publication Number:
  US 20080112958A1
• Time in Patent Office: 1,359 Days
• Field of Search: None
• US Class Current: 435/6
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/335 having oxygen as the only ring hetero atom, e.g. fungichromin
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/39558 against tumor tissues, cells, antigens
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/14 for lactation disorders, e.g. galactorrhoea
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/2863 against receptors for growth factors, growth regulators
• CPC Class Codes: C07K 16/32 against translation products of oncogenes
• CPC Class Codes: C07K 16/40 against enzymes
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C12Q 1/6841 In situ hybridisation
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2537/157 A reaction step characterised by the number of molecules incorporated or released
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 33/5023 : on expression patterns
• CPC Class Codes: G01N 33/57415 : of breast

Abstract

The invention provides a method for more effective treatment of patients susceptible to or diagnosed with tumors overexpressing ErbB, as determined by a gene amplification assay, with an ErbB antagonist. Such method comprises administering a cancer-treating dose of the ErbB antagonist, preferably in addition to chemotherapeutic agents, to a subject in whose tumor cells ErbB has been found to be amplified e.g., by fluorescent in situ hybridization. ErbB antagonists described include an anti-HER2 antibody. Pharmaceutical packaging for providing the components for such treatment is also provided.

Claims

1. A method for increasing likelihood of effectiveness of breast cancer treatment with humanized anti-ErbB2 antibody huMAb4D5-8, which method comprises administering a cancer treating dose of said antibody to a human subject diagnosed with breast cancer, wherein an erbB2 gene amplification in breast cancer cells in a tissue sample from the subject has been detected, and wherein the breast cancer cells from the human subject have been found to have a 0 or 1+ score of ErbB2 protein expression by immunohistochemistry.

2. The method according to claim 1, wherein the breast cancer cells from the human subject have been found to have a 0 or 1+ score of ErbB2 protein expression by immunohistochemistry on a formaldehyde-fixed tissue sample.

3. The method according to claim 1 wherein the erbB2 gene amplification is detected by detecting fluorescence of a fluorescent-labeled nucleic acid probe hybridized to the gene.

4. The method according to claim 1, which further comprises administering a cancer treating dose of a chemotherapeutic drug.

5. The method according to claim 4, wherein the chemotherapeutic drug is a taxoid.

6. The method according to claim 1 wherein the likelihood of effectiveness increases by about 30%.