CA2311409A1 - Treatment with anti-erbb2 antibodies - Google Patents

Treatment with anti-erbb2 antibodies Download PDF

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Publication number
CA2311409A1
CA2311409A1 CA002311409A CA2311409A CA2311409A1 CA 2311409 A1 CA2311409 A1 CA 2311409A1 CA 002311409 A CA002311409 A CA 002311409A CA 2311409 A CA2311409 A CA 2311409A CA 2311409 A1 CA2311409 A1 CA 2311409A1
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CA
Canada
Prior art keywords
cancer
erbb2
antibody
article
manufacture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002311409A
Other languages
French (fr)
Other versions
CA2311409C (en
Inventor
Steven Shak
Virginia E. Paton
Susan D. Hellmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genentech Inc
Original Assignee
Genentech, Inc.
Steven Shak
Virginia E. Paton
Susan D. Hellmann
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22088358&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2311409(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc., Steven Shak, Virginia E. Paton, Susan D. Hellmann filed Critical Genentech, Inc.
Priority to CA2730373A priority Critical patent/CA2730373A1/en
Publication of CA2311409A1 publication Critical patent/CA2311409A1/en
Application granted granted Critical
Publication of CA2311409C publication Critical patent/CA2311409C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Abstract

The present invention concerns the treatment of disorders characterized by the overexpression of ErbB2. More specifically, the invention concerns the treatment of human patients susceptible to or diagnosed with cancer overexpressing ErbB2 with a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline, e.g. doxorubicin or epirubicin.

Claims (19)

1. A method for the treatment of a human patient susceptible to or diagnosed with a disorder characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline derivative, in the absence of an anthracycline derivative, to the human patient.
2. The method of claim 1 wherein said disorder is a benign or malignant tumor.
3. The method of claim 1 wherein said disorder is a cancer.
4. The method of claim 3 wherein said cancer is selected from the group consisting of breast cancer, squamous cell cancer, small-cell lung cancer, non-small cell lung cancer, gastrointestinal cancer, pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, liver cancer, bladder cancer, hepatoma, colon cancer, colorectal cancer, endometrial carcinoma, salivary gland carcinoma, kidney cancer, liver cancer, prostate cancer, vulval cancer, thyroid cancer, hepatic carcinoma and various types of head and neck cancer.
5. The method of claim 4 wherein said cancer is breast cancer.
6. The method of claim 5 wherein said cancer is metastatic breast carcinoma.
7. The method of claim 1 wherein said antibody binds to the extracellular domain of the ErbB2 receptor.
8. The method of claim 7 wherein said antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.
9. The method of claim 8 wherein said antibody is a humanized 4D5 anti-ErbB2 antibody.
10. The method of claim 1 wherein said chemotherapeutic agent is a taxoid.
11. The method of claim 10 wherein said taxoid is paclitaxel or doxetaxel.
12. The method of claim 1 wherein the effective amount of said combination is lower than the sum of the effective amounts of said anti-ErbB2 antibody and said chemotherapeutic agent, when administered individually, as single agents.
13. The method of claim 1 wherein efficacy is measured by determining the time to disease progression or the response rate.
14. An article of manufacture, comprising a container, a composition within the container comprising an anti-ErbB2 antibody, and a package insert containing instructions to avoid the use of anthracycline-type chemotherapeutics in combination with said composition.
15. The article of manufacture of claim l4 further comprising a label on or associated with the container that indicates that said composition can be used for treating a condition characterized by overexpression of ErbB2 receptor.
16. The article of manufacture of claim 15 wherein said label indicates that said composition can be used for the treatment of breast cancer.
17. The article of manufacture of claim 15 wherein said anti-ErbB2 antibody binds to the extracellular domain of the receptor.
18. The article of manufacture of claim 17 wherein said anti-ErbB2 antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.
19. The article of manufacture of claim 18 wherein said antibody is a humanized 4D5 anti-ErbB2 antibody.
CA2311409A 1997-12-12 1998-12-10 Treatment with anti-erbb2 antibodies Expired - Lifetime CA2311409C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2730373A CA2730373A1 (en) 1997-12-12 1998-12-10 Treatment of cancer having overexpression of erbb2 with anti-erbb2 antibodies and a hormonal chemotherapeutic agent

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US6934697P 1997-12-12 1997-12-12
US60/069,346 1997-12-12
PCT/US1998/026266 WO1999031140A1 (en) 1997-12-12 1998-12-10 TREATMENT WITH ANTI-ErbB2 ANTIBODIES

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2730373A Division CA2730373A1 (en) 1997-12-12 1998-12-10 Treatment of cancer having overexpression of erbb2 with anti-erbb2 antibodies and a hormonal chemotherapeutic agent

Publications (2)

Publication Number Publication Date
CA2311409A1 true CA2311409A1 (en) 1999-06-24
CA2311409C CA2311409C (en) 2011-04-12

Family

ID=22088358

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2730373A Abandoned CA2730373A1 (en) 1997-12-12 1998-12-10 Treatment of cancer having overexpression of erbb2 with anti-erbb2 antibodies and a hormonal chemotherapeutic agent
CA2311409A Expired - Lifetime CA2311409C (en) 1997-12-12 1998-12-10 Treatment with anti-erbb2 antibodies

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2730373A Abandoned CA2730373A1 (en) 1997-12-12 1998-12-10 Treatment of cancer having overexpression of erbb2 with anti-erbb2 antibodies and a hormonal chemotherapeutic agent

Country Status (18)

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US (11) US7846441B1 (en)
EP (3) EP2275450A1 (en)
JP (7) JP2002508397A (en)
KR (7) KR20080075042A (en)
CN (2) CN1820734B (en)
AR (1) AR020051A1 (en)
AU (1) AU1908199A (en)
BR (1) BR9815363A (en)
CA (2) CA2730373A1 (en)
DK (1) DK1037926T3 (en)
ES (1) ES2450922T3 (en)
HK (2) HK1030784A1 (en)
IL (4) IL136201A0 (en)
NO (2) NO20002957L (en)
NZ (1) NZ504597A (en)
TR (1) TR200001689T2 (en)
WO (1) WO1999031140A1 (en)
ZA (1) ZA9811162B (en)

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