Claims for Patent: 9,518,130

Summary for Patent: 9,518,130

Title:	Use of ERBB3 inhibitors in the treatment of triple negative and basal-like breast cancers
Abstract:	Provided are methods of suppressing growth of triple negative breast tumors and basal-like breast tumors by contacting tumor cells with an ErbB3 inhibitor, e.g., an anti-ErbB3 antibody. Also provided are methods for treating triple negative breast cancer or basal-like breast cancer in a patient by administering to the patient an ErbB3 inhibitor, e.g., an anti-ErbB3 antibody. The treatment methods can further comprise selecting a patient having a triple negative breast cancer or basal-like breast cancer and then administering an ErbB3 inhibitor to the patient. The treatment methods also can further comprise administering at least one additional anti-cancer agent to the patient in combination with the ErbB3 inhibitor.
Inventor(s):	Moyo; Victor (Ringoes, NJ), Garcia; Gabriela (Roslindale, MA)
Assignee:	Merrimack Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	14/518,900
Patent Claims:	1. A method of treating a patient having a tumor that expresses ErbB3and is identified as a triple negative breast cancer, the method comprising administering to the patient an effective amount of an anti-ErbB3 antibody, or antigen-binding fragment thereof, comprising a V.sub.H CDR1 sequence of SEQ ID NO:3, a V.sub.H CDR2 sequence of SEQ ID NO:4 and a V.sub.H CDR3 sequence of SEQ ID NO:5, and a V.sub.L CDR1 sequence of SEQ ID NO:6, a V.sub.L CDR2 sequence of SEQ ID NO:7 and a V.sub.L CDR3 sequence of SEQ ID NO:8, that binds to all or a portion of residues 92-104 of SEQ ID NO:41. 2. The method of claim 1, wherein the anti-ErbB3 antibody binds to the same epitope as an antibody comprising a V.sub.H sequence as shown in SEQ ID NO:1 and a V.sub.Lsequence as shown in SEQ ID NO:2. 3. The method of claim 1, wherein administration of the effective amount of the anti-ErbB3 antibody suppresses growth of the triple negative breast cancer tumor. 4. The method of claim 1, wherein the triple negative breast cancer is histopathologically characterized as having a basal-like phenotype. 5. The method of claim 1, wherein the triple negative breast cancer is histopathologically characterized as having a phenotype other than basal-like. 6. The method of claim 1, which further comprises administering to the patient an effective amount of at least one additional anti-cancer agent. 7. The method of claim 6, wherein the at least one additional anti-cancer agent is selected from the group consisting of platinum-based chemotherapy drugs, taxanes, tyrosine kinase inhibitors, anti-EGFR antibodies, anti-ErbB2 antibodies, and combinations thereof. 8. The method of claim 7, wherein the at least one additional anti cancer agent is a taxane and the taxane is paclitaxel. 9. The method of claim 6, wherein the at least one additional anti-cancer agent comprises an EGFR inhibitor. 10. The method of claim 9, wherein the EGFR inhibitor comprises an anti-EGFR antibody. 11. The method of claim 10, wherein the anti-EGFR antibody is selected from the group consisting of cetuximab, matuzumab, panitumumab, nimotuzumab and mAb 806. 12. The method of claim 9, wherein the EGFR inhibitor is a small molecule inhibitor of EGFR signaling selected from the group consisting of gefitinib, lapatinib, canertinib, pelitinib, and erlotinib HCL. 13. The method of claim 6, wherein the at least one additional anti-cancer agent comprises a VEGF inhibitor. 14. The method of claim 13, wherein the VEGF inhibitor comprises bevacizumab. 15. The method of claim 1, wherein the triple negative breast cancer tumor is a tumor which scores negative for estrogen receptor (ER) and progesterone receptor and yields a test result of 0, 1+, or 2+ using a semi-quantitative immunohistochemical assay using a polyclonal anti-HER2 primary antibody. 16. The method of claim 15, wherein the tumor is FISH negative for HER2 gene amplification. 17. A method of treating a patient having a tumor that expresses ErbB3and is identified as a triple negative breast cancer which has a basal-like phenotype, the method comprising administering to the patient an effective amount of an anti-ErbB3 antibody, or antigen-binding fragment thereof, comprising a V.sub.H CDR1 sequence of SEQ ID NO:3, a V.sub.H CDR2 sequence of SEQ ID NO:4 and a V.sub.H CDR3 sequence of SEQ ID NO:5, and a V.sub.L CDR1 sequence of SEQ ID NO:6, a V.sub.L CDR2 sequence of SEQ ID NO:7 and a V.sub.L CDR3 sequence of SEQ ID NO:8 that binds to all or a portion of residues 92-104 of SEQ ID NO:41. 18. The method of claim 17, wherein the anti-ErbB3 antibody binds to the same epitope as an antibody comprising a V.sub.H sequence as shown in SEQ ID NO:1 and a V.sub.Lsequence as shown in SEQ ID NO:2. 19. The method of claim 17, wherein the administration of the effective amount of the anti-ErbB3 antibody suppresses growth of the breast cancer tumor. 20. The method of claim 17, which further comprises administering to the patient an effective amount of at least one additional anti-cancer agent. 21. The method of claim 20, wherein the at least one additional anti-cancer agent is a taxane. 22. The method of claim 21, wherein the taxane is paclitaxel.

Details for Patent 9,518,130

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2030-03-11
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2030-03-11
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2030-03-11
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2030-03-11