US2015093381A1PendingUtilityA1

Fixed dosing of her antibodies

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Assignee: GENENTECH INCPriority: Jan 21, 2005Filed: Nov 26, 2014Published: Apr 2, 2015
Est. expiryJan 21, 2025(expired)· nominal 20-yr term from priority
Inventors:David E. AllisonRene BrunoJian-Feng LuChee Ming Ng
A61P 35/04A61P 35/00A61P 15/00A61P 1/04A61P 13/08A61P 11/00A61K 31/704A61K 31/7068A61K 39/39558C07K 16/32A61K 38/18A61K 2039/545C07K 16/2863A61K 2039/505Y10T428/13C07K 2317/56A61K 45/06A61J 1/065A61K 31/337C07K 2317/76A61K 39/3955C07K 16/22C07K 2317/24A61K 2039/54C07K 2317/94C07K 16/40A61K 39/395
63
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treating cancer comprising administering one or more fixed dose(s) of a HER antibody to a human patient in an amount effective to treat the cancer. 
     
     
         2 . The method of  claim 1  wherein the antibody binds to a HER receptor selected from the group consisting of EGFR, HER2, and HER3. 
     
     
         3 . The method of  claim 2  wherein the antibody binds to HER2. 
     
     
         4 . The method of  claim 3  wherein the HER2 antibody binds to Domain II of HER2 extracellular domain. 
     
     
         5 . The method of  claim 1  wherein the antibody binds to a junction between domains I, II and III of HER2 extracellular domain. 
     
     
         6 . The method of  claim 1  wherein the HER antibody inhibits heterodimerization of HER2 with EGFR or HER3. 
     
     
         7 . The method of  claim 1  wherein the HER antibody comprises the variable light and variable heavy amino acid sequences in SEQ ID Nos. 3 and 4, respectively. 
     
     
         8 . The method of  claim 1  wherein the HER antibody is pertuzumab. 
     
     
         9 . The method of  claim 1  wherein the fixed dose is in the range from about 20 mg to about 2000 mg of the HER antibody. 
     
     
         10 . The method of  claim 9  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 HER antibody. 
     
     
         11 . The method of  claim 10  wherein the fixed dose is 420 mg of the HER antibody. 
     
     
         12 . The method of  claim 10  wherein the fixed dose is 840 mg of the HER antibody. 
     
     
         13 . The method of  claim 10  wherein the fixed dose is 1050 mg of the HER antibody. 
     
     
         14 . The method of  claim 10  wherein the fixed dose is 525 mg of the HER antibody. 
     
     
         15 . The method of  claim 1  wherein a fixed dose of the HER antibody is administered to the patient approximately every week, approximately every 2 weeks, approximately every 3 weeks, or approximately every 4 weeks. 
     
     
         16 . The method of  claim 15  wherein a fixed dose of the HER antibody is administered to the patient approximately every 3 weeks. 
     
     
         17 . The method of  claim 10  comprising administering a loading dose of approximately 840 mg of the HER antibody followed by one or more maintenance doses of approximately 420 mg of the HER antibody. 
     
     
         18 . The method of  claim 17  wherein the maintenance doses are administered approximately every 3 weeks. 
     
     
         19 . The method of  claim 10  comprising administering a loading dose of approximately 1050 mg of the HER antibody followed by one or more maintenance doses of approximately 525 mg of the HER antibody. 
     
     
         20 . The method of  claim 19  wherein the maintenance doses are administered approximately every 3 weeks. 
     
     
         21 . The method of  claim 1  wherein the HER antibody is a naked antibody. 
     
     
         22 . The method of  claim 1  wherein the HER antibody is an intact antibody. 
     
     
         23 . The method of  claim 1  wherein the HER antibody is an antibody fragment comprising an antigen binding region. 
     
     
         24 . The method of  claim 1  wherein the HER antibody is a humanized or human IgG1 antibody. 
     
     
         25 . The method of  claim 1  wherein the cancer displays HER expression, amplification, or activation. 
     
     
         26 . The method of  claim 1  wherein the cancer is ovarian, peritoneal, or fallopian tube cancer. 
     
     
         27 . The method of  claim 1  wherein the cancer is metastatic breast cancer (MBC). 
     
     
         28 . The method of  claim 1  wherein the cancer is non-small cell lung cancer (NSCLC). 
     
     
         29 . The method of  claim 1  wherein the cancer is prostate cancer. 
     
     
         30 . The method of  claim 1  wherein the cancer is colorectal cancer. 
     
     
         31 . The method of  claim 1  comprising administering a second therapeutic agent to the patient. 
     
     
         32 . The method of  claim 31  wherein the second therapeutic agent is selected from the group consisting of chemotherapeutic agent, different HER 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. 
     
     
         33 . The method of  claim 32  wherein the second therapeutic agent is a chemotherapeutic agent. 
     
     
         34 . The method of  claim 33  wherein the chemotherapeutic agent is an antimetabolite chemotherapeutic agent. 
     
     
         35 . The method of  claim 34  wherein the antimetabolite chemotherapeutic agent is gemcitabine. 
     
     
         36 . The method of  claim 31  wherein the second therapeutic agent is trastuzumab, erlotinib HCL, or bevacizumab. 
     
     
         37 . A method of treating 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. 
     
     
         38 . The method of  claim 37  wherein a fixed dose of pertuzumab is administered to the patient approximately every 3 weeks. 
     
     
         39 . The method of  claim 37  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. 
     
     
         40 . The method of  claim 37  wherein the fixed dose is selected from the group consisting of 420 mg, 525 mg, 840 mg, and 1050 mg of pertuzumab. 
     
     
         41 . An article of manufacture comprising a vial containing a fixed dose of a HER antibody, 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 HER antibody. 
     
     
         42 . The article of manufacture of  claim 41  wherein the HER antibody is pertuzumab. 
     
     
         43 . The article of manufacture of  claim 41  wherein the fixed dose is selected from the group consisting of 420 mg, 525 mg, 840 mg, and 1050 mg of the HER antibody. 
     
     
         44 . The article of manufacture of  claim 41  further comprising a package insert instructing the user to administer the fixed dose to a cancer patient. 
     
     
         45 . The article of manufacture of  claim 44  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. 
     
     
         46 . The article of manufacture of  claim 44  wherein the package insert further instructs the user to administer the fixed dose to a cancer patient whose cancer displays HER expression, amplification, or activation. 
     
     
         47 . The article of manufacture of  claim 41  comprising two vials, wherein a first vial contains a fixed dose of approximately 840 mg of pertuzumab, and a second vial contains a fixed dose of approximately 420 mg of pertuzumab. 
     
     
         48 . The article of manufacture of  claim 41  comprising two vials, wherein a first vial contains a fixed dose of approximately 1050 mg of pertuzumab, and a second vial contains a fixed dose of approximately 525 mg of pertuzumab.

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