Claims for Patent: 8,940,302

Summary for Patent: 8,940,302

Title:	Predicting response to a HER inhibitor
Abstract:	The present application describes the use of low HER3 as a selection criterion for treating patients with a HER inhibitor, such as pertuzumab. It also describes the use of high HER2:HER3 ratio as a selection criterion for treating cancer patients, such as ovarian cancer patients, with a HER inhibitor, such as pertuzumab. In addition, the application describes the use of high HER3 as a selection criterion for treating cancer patients with a chemotherapeutic agent, for instance gemcitabine.
Inventor(s):	Amler; Lukas C. (Foster City, CA), Birkner; Merrill (San Francisco, CA), Lin; Chin-Yu (Redwood City, CA), Moecks; Joachim (Mannheim, DE), Strauss; Andreas (Penzberg, DE)
Assignee:	Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	13/648,085
Patent Claims:	1. A method for treating a patient with a type of cancer which is able to respond to a HER2 dimerization inhibitor antibody, comprising administering to the patient a therapeutically effective amount the HER2 antibody, wherein the patient's cancer has been determined to express HER3 at a level less than the median level for HER3 expression in the cancer type, and 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 patient's cancer expresses HER3 at a level which is less than the 25.sup.th percentile for HER3 expression in the cancer type. 3. The method of claim 1 wherein HER3 expression has been determined using polymerase chain reaction (PCR). 4. The method of claim 3 wherein the PCR is quantitative real time polymerase chain reaction (qRT-PCR). 5. The method of claim 1 wherein the HER2 antibody is pertuzumab. 6. The method of claim 1 wherein the HER2 antibody is a naked antibody. 7. The method of claim 1 wherein the HER2 antibody is an intact antibody. 8. The method of claim 1 wherein the HER2 antibody is an antibody fragment comprising an antigen binding region. 9. The method of claim 1 wherein the cancer type 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. 10. The method of claim 1 which extends progression free survival (PFS) in the patient. 11. The method of claim 1 which extends overall survival (OS) in the patient. 12. The method of claim 1 wherein the HER2 antibody is administered as a single anti-tumor agent. 13. The method of claim 1 comprising administering a second therapeutic agent to the patient. 14. The method claim 13 wherein the second therapeutic agent is selected from the group consisting of chemotherapeutic agent, HER antibody, antibody directed against a 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, HER targeting therapy, Raf or ras inhibitor, liposomal doxorubicin, 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 medicament that treats or prevents diarrhea, a body temperature-reducing medicament, and a hematopoietic growth factor. 15. The method of claim 14 wherein the second therapeutic agent is a chemotherapeutic agent. 16. The method of claim 15 wherein the chemotherapeutic agent is selected from the group consisting of gemcitabine, carboplatin, paclitaxel, docetaxel, topotecan, and liposomal doxorubicin. 17. The method of claim 14 wherein the second therapeutic agent is trastuzumab, erlotinib, or bevacizumab. 18. The method of claim 1 wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the 25.sup.th percentile for HER2:HER3 expression in the cancer type. 19. The method of claim 18 wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the median level for HER2:HER3 expression in the cancer type. 20. The method of claim 19 wherein the patient's cancer expresses HER2:HER3 at a level which is greater than the 75.sup.th percentile for HER2:HER3 expression in the cancer type. 21. A method for treating a patient with a type of cancer which is able to respond to pertuzumab, comprising administering to the patient a therapeutically effective amount of pertuzumab, wherein the patient's cancer has been determined to express HER3 at a level less than the median level for HER3 expression in the cancer type. 22. A method for treating a patient with a type of cancer which is able to respond to a HER2 dimerization inhibitor antibody that binds to a heterodimeric binding site of HER2, comprising administering to the patient a therapeutically effective amount the HER2 antibody, wherein the patient's cancer has been determined to express HER3 at a level less than the median level for HER3 expression in the cancer type, and the wherein the cancer type is selected from the group consisting of ovarian cancer, peritoneal cancer, fallopian tube cancer, breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, and colorectal cancer. 23. A method for treating a patient with a type of cancer which is able to respond to pertuzumab, comprising administering to the patient a therapeutically effective amount of pertuzumab, wherein the patient's cancer has been determined to express HER3 at a level less than the median level for HER3 expression in the cancer type, and the wherein the cancer type is selected from the group consisting of ovarian cancer, peritoneal cancer, fallopian tube cancer, breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, and colorectal cancer.

Details for Patent 8,940,302

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2027-03-02
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2027-03-02
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2027-03-02
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409	06/08/2012		2027-03-02
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2027-03-02