Claims for Patent: 8,512,967

Summary for Patent: 8,512,967

Title:	Method for predicting the response to HER2-directed therapy
Abstract:	This invention provides methods for determining or predicting response to HER2-directed therapy in an individual.
Inventor(s):	Bacus; Sarah S. (Hinsdale, IL), Smith; Bradley L. (Marblehead, MA)
Assignee:	Ventana Medical Systems, Inc. (Tucson, AZ) Cell Signaling Technology, Inc. (Beverly, MA)
Application Number:	13/025,600
Patent Claims:	1. A method for identifying a breast tumor likely to respond to trastuzumab, comprising: measuring by immunohistochemistry in a tissue sample obtained from the breast tumor: a) expression of epidermal growth factor receptor (EGFR) polypeptide; and b) phosphorylation of extracellular signal-regulated kinase (ERK) polypeptide, wherein phosphorylation of ERK polypeptide is measured using an antibody specific for an epitope comprising a phosphorylated threonine at position 202 of SEQ ID NO: 3, a phosphorylated tyrosine at position 204 of SEQ ID NO: 3, or a combination thereof; and identifying the breast tumor as a breast tumor likely to respond to trastuzumab, if the breast tumor is positive for EGFR polypeptide expression and negative for phosphorylation of ERK polypeptide. 2. The method of claim 1, wherein the sample is a biopsy sample. 3. The method of claim 2, wherein the biopsy sample is a paraffin-embedded sample. 4. The method of claim 1, further comprising identifying the breast tumor as not likely to respond to trastuzumab if the breast tumor is negative for EGFR polypeptide expression and positive for phosphorylation of ERK polypeptide. 5. A method for selecting a subject with a breast tumor for treatment with trastuzumab, comprising: measuring by immunohistochemistry in a tissue sample obtained from the breast tumor: a) expression of epidermal growth factor receptor (EGFR) polypeptide; and b) phosphorylation of extracellular signal-regulated kinase (ERK) polypeptide, wherein phosphorylation of ERK polypeptide is measured using an antibody specific for an epitope comprising a phosphorylated threonine at position 202 of SEQ ID NO: 3, a phosphorylated tyrosine at position 204 of SEQ ID NO: 3, or a combination thereof; identifying the breast tumor as a breast tumor likely to respond to trastuzumab if the breast tumor is positive for EGFR polypeptide expression and negative for phosphorylation of ERK polypeptide; and selecting a subject with a breast tumor identified as likely to respond to trastuzumab for treatment with trastuzumab. 6. The method of claim 5, wherein the sample is a biopsy sample. 7. The method of claim 6, wherein the biopsy sample is a paraffin-embedded sample. 8. The method of claim 5, wherein the breast tumor has previously been treated with at least one chemotherapeutic. 9. The method of claim 8, wherein the chemotherapeutic comprises cisplatin, doxorubicin, or taxol. 10. The method of claim 5, further comprising not selecting the subject for treatment with trastuzumab if the breast tumor is negative for EGFR polypeptide expression and positive for phosphorylation of ERK polypeptide. 11. The method of claim 5, further comprising administering trastuzumab to the selected subject. 12. A method for identifying a breast tumor likely to respond to trastuzumab, comprising: measuring in a sample obtained from the breast tumor: a) expression of epidermal growth factor receptor (EGFR) polypeptide; and b) phosphorylation of extracellular signal-regulated kinase (ERK) polypeptide, wherein phosphorylation of ERK polypeptide is measured using an antibody specific for an epitope comprising a phosphorylated threonine at position 202 of SEQ ID NO: 3, a phosphorylated tyrosine at position 204 of SEQ ID NO: 3, or a combination thereof; identifying the breast tumor as a breast tumor likely to respond to trastuzumab, if the breast tumor is positive for EGFR polypeptide expression and negative for phosphorylation of ERK polypeptide; and administering trastuzumab to the subject from which the breast tumor sample was obtained if the breast tumor is positive for EGFR polypeptide expression and negative for phosphorylation of ERK polypeptide.

Details for Patent 8,512,967

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2022-04-05
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2022-04-05
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2022-04-05