Fixed dosing of HER antibodies

• US 7,449,184 B2
• Filed: 06/15/2005
• Issued: 11/11/2008
• Est. Priority Date: 01/21/2005
• Status: Active Grant

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Lu, Jian-Feng, Allison, David E., Ng, Chee M., Bruno, Rene
• Primary Examiner(s): Helms; Larry R.
• Assistant Examiner(s): Goddard; Laura B
• Application Number:
  US11/154,091
• Publication Number:
  US 20060165702A1
• Time in Patent Office: 1,245 Days
• Field of Search: None
• US Class Current: 424/138.1
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/7068 having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 39/39558 against tumor tissues, cells, antigens
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: C07K 16/22 against growth factors ; against 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: C07K 2317/56 : variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/76 : Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C07K 2317/94 : Stability, e.g. half-life, pH, temperature or enzyme-resistance
• CPC Class Codes: Y10T 428/13 : Hollow or container type article [e.g., tube, vase, etc.]

Abstract

The present invention concerns fixed dosing of HER antibodies, such as Pertuzumab.

Claims

1. A method for treating HER2 expressing cancer comprising administering one or more fixed dose(s) of HER2 antibody to a human patient in an amount effective to treat the cancer, wherein the fixed dose is selected from the group consisting of approximately 420 mg, approximately 525 mg, approximately 840 mg, and approximately 1050 mg of the HER2 antibody, wherein the HER2 antibody comprises the variable light and variable heavy amino acid sequences in SEQ ID Nos. 3 and 4, respectively.

2. The method of claim 1 wherein the HER2 antibody is pertuzumab.

3. The method of claim 1 wherein the fixed dose is 420 mg of the HER2 antibody.

4. The method of claim 1 wherein the fixed dose is 840 mg of the HER2 antibody.

5. The method of claim 1 wherein the fixed dose is 1050 mg of the HER2 antibody.

6. The method of claim 1 wherein the fixed dose is 525 mg of the HER2 antibody.

7. The method of claim 1 wherein a fixed dose of the HER2 antibody is administered to the patient approximately every week, approximately every 2 weeks, approximately every 3 weeks, or approximately every 4 weeks.

8. The method of claim 7 wherein a fixed dose of the HER2 antibody is administered to the patient approximately every 3 weeks.

9. The method of claim 1 comprising administering a loading dose of approximately 840 mg of the HER2 antibody followed by one or more maintenance doses of approximately 420 mg of the HER2 antibody.

10. The method of claim 9 wherein the maintenance doses are administered approximately every 3 weeks.

11. The method of claim 1 comprising administering a loading dose of approximately 1050 mg of the HER2 antibody followed by one or more maintenance doses of approximately 525 mg of the HER2 antibody.

12. The method of claim 11 wherein the maintenance doses are administered approximately every 3 weeks.

13. The method of claim 1 wherein the HER2 antibody is a naked antibody.

14. The method of claim 1 wherein the HER2 antibody is an intact antibody.

15. The method of claim 1 wherein the HER2 antibody is an antibody fragment comprising an antigen binding region.

16. The method of claim 1 wherein the HER2 antibody is a humanized or human IgG1antibody.

17. The method of claim 1 wherein the cancer displays HER2 expression, amplification, or activation.

18. The method of claim 1 wherein the cancer is ovarian, peritoneal, or fallopian tube cancer.

19. The method of claim 1 wherein the cancer is metastatic breast cancer (MBC).

20. The method of claim 1 wherein the cancer is non-small cell lung cancer (NSCLC).

21. The method of claim 1 wherein the cancer is prostate cancer.

22. The method of claim 1 wherein the cancer is colorectal cancer.

23. The method of claim 1 comprising administering a second therapeutic agent to the patient.

24. The method of claim 23 wherein the second therapeutic agent is selected from the group consisting of chemotherapeutic agent, different HER2 antibody, antibody directed against a different tumor associated antigen, anti-hormonal compound, cardioprotectant, cytokine, EGFR-targeted drug, anti-angiogenic agent, tyrosine kinase inhibitor, COX inhibitor, non-steroidal anti-inflammatory drug, farnesyl transferase inhibitor, antibody that binds oncofetal protein CA 125, HER2 vaccine, another HER targeting therapy, Raf or ras inhibitor, doxorubicin HCL liposome injection, topotecan, taxane, dual tyrosine kinase inhibitor, TLK286, EMD-7200, a medicament that treats nausea, a medicament that prevents or treats skin rash or standard acne therapy, a body temperature-reducing medicament, and a hematopoietic growth factor.

25. The method of claim 24 wherein the second therapeutic agent is a chemotherapeutic agent.

26. The method of claim 25 wherein the chemotherapeutic agent is an antimetabolite chemotherapeutic agent.

27. The method of claim 26 wherein the antimetabolite chemotherapeutic agent is gemcitabine.

28. The method of claim 23 wherein the second therapeutic agent is trastuzumab, erlotinib HCL, or bevacizumab.

29. A method of treating HER2 expressing cancer in a human patient comprising administering at least one fixed dose of pertuzumab to the patient, wherein the fixed dose is selected from the group consisting of approximately 420 mg, approximately 525 mg, approximately 840 mg, and approximately 1050 mg of pertuzumab.

30. The method of claim 29 wherein a fixed dose of pertuzumab is administered to the patient approximately every 3 weeks.

31. The method of claim 29 wherein the cancer is selected from the group consisting of ovarian cancer, peritoneal cancer, fallopian tube cancer, metastatic breast cancer (MBC), non-small cell lung cancer (NSCLC), prostate cancer, and colorectal cancer.

32. The method of claim 29 wherein the fixed dose is selected from the group consisting of 420 mg, 525 mg, 840 mg, and 1050 mg of pertuzumab.