METHODS OF TREATING METASTATIC BREAST CANCER WITH TRASTUZUMAB-MCC-DM1

• US 20110165155A1
• Filed: 12/03/2010
• Published: 07/07/2011
• Est. Priority Date: 12/04/2009
• Status: Abandoned Application

• Current Assignee: F Hoffmann-La Roche AG (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Agresta, Samuel, Klencke, Barbara
• Application Number:
  US12/959,975
• Publication Number:
  US 20110165155A1
• Time in Patent Office: Days
• US Class Current: 424/133.1
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• 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 31/537 spiro-condensed or forming part of bridged ring systems
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/6803 Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
• CPC Class Codes: A61K 47/6849 the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
• CPC Class Codes: A61K 47/6855 the tumour determinant being from breast cancer cell
• CPC Class Codes: A61K 47/6889 Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: C07K 16/32 against translation products of oncogenes

Abstract

Methods of treating patients having metastatic or unresectable locally advanced HER2 positive cancer, e.g., breast cancer, with the antibody-drug conjugate trastuzumab-MCC-DM1 are provided, wherein the patients have received extensive prior treatment, e.g., with an anthracycline, a taxane, capecitabine, lapatinib, and trastuzumab.

Claims

1. A method for the treatment of metastatic or unresectable locally advanced HER2 positive cancer in a patient comprising administering a therapeutically effective amount of trastuzumab-MCC-DM1, wherein the patient has been previously treated with at least two anti-HER2 agents.

2. The method of claim 1, wherein the at least two anti-HER2 agents are lapatinib and trastuzumab.

3. The method of claim 1 or 2, wherein the patient has been previously treated with an anthracycline, a taxane, and capecitabine.

4. The method of any of claims 1-3, wherein the cancer is breast cancer.

5. The method of claim 1, wherein trastuzumab-MCC-DM1 is administered at three week intervals to the patient.

6. The method of claim 1, wherein the therapeutically effective amount of trastuzumab-MCC-DM1 is 1 mg to 10 mg/kg/day of patient body weight.

7. The method of claim 1, wherein trastuzumab-MCC-DM1 is formulated with sodium succinate, pH 5.0, and 0.02% (w/v) polysorbate 20.

8. The method of claim 7, wherein trastuzumab-MCC-DM1 is further formulated with 6% (w/v) trehalose dihydrate or 6% (w/v) sucrose.

9. A method for the treatment of metastatic or unresectable locally advanced HER2 positive cancer in a patient comprising administering a therapeutically effective amount of trastuzumab-MCC-DM1, wherein the patient was previously treated with two or more therapies selected from an anthracycline, a taxane, capecitabine, lapatinib, and trastuzumab, and wherein the patient progressed on their most recent treatment.

10. The method of claim 9, wherein the cancer is breast cancer.

11. The method of claim 9, wherein trastuzumab-MCC-DM1 is administered at three week intervals to the patient.

12. The method of claim 9, wherein the therapeutically effective amount of trastuzumab-MCC-DM1 is 1 mg to 10 mg/kg/day of patient body weight.

13. The method of claim 9, wherein trastuzumab-MCC-DM1 is formulated with sodium succinate, pH 5.0, and 0.02% (w/v) polysorbate 20.

14. The method of claim 9, wherein trastuzumab-MCC-DM1 is further formulated with 6% (w/v) trehalose dihydrate or 6% (w/v) sucrose.