Claims for Patent: 9,415,050

Summary for Patent: 9,415,050

Title:	Methods for the treatment of HER2 amplified cancer
Abstract:	Described herein are methods and compositions for treating HER2-amplified cancer. The methods include administering to an individual in need thereof ibrutinib.
Inventor(s):	Chen; Jun (San Jose, CA), Buggy; Joseph J. (Mountain View, CA), Elias; Laurence (Berkeley, CA)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	14/458,157
Patent Claims:	1. A method for treating a refractory HER2-amplified breast cancer in an individual in need thereof comprising administering to an individual in need thereof a composition comprising (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)pi- peridin-1-yl)prop-2-en-1-one ##STR00020## 2. The method of claim 1, wherein the refractory HER2-amplified breast cancer is metastatic. 3. The method of claim 1, wherein the refractory HER2-amplified breast cancer is refractory to a treatment of trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, or MM-111. 4. The method of claim 1, wherein the refractory HER2-amplified breast cancer has a HER2:CEP17 ratio of 2.2-4.0 or >4.0. 5. The method of claim 1, further comprising co-administering an additional therapeutic agent. 6. The method of claim 5, wherein the additional therapeutic agent is an anti-HER2 therapeutic agent, a pan-ErbB inhibitor, or an anti-VEGF therapeutic agent. 7. The method of claim 6, wherein the anti-HER2 therapeutic agent is selected from the group consisting of: trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, and MM-111. 8. The method of claim 6, wherein the pan-ErbB inhibitor is selected from the group consisting of: afatinib, neratinib, and dacomitinib. 9. The method of claim 6, wherein the anti-VEGF therapeutic agent is selected from the group consisting of: bevacizumab, ranibizumab, lapatinib, sunitinib, sorafenib, axitinib, and pazopanib. 10. The method of claim 5, wherein the additional therapeutic agent is selected from the group consisting of: temsirolimus; paclitaxel; varlitinib; vorinostat; doxorubicin; cyclophosphamide; cisplatin; docetaxel; dasatinib; trastuzumab and docetaxel; pertuzumab and docetaxel; doxorubicin, cyclophosphamide and paclitaxal; and doxorubicin, cyclophosphamide and fluorouracil. 11. A method for treating a refractory HER2 amplified cancer in an individual in need thereof comprising administering to an individual in need thereof a composition comprising (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)pi- peridin-1-yl)prop-2-en-1-one ##STR00021## 12. The method of claim 11, wherein the refractory HER2-amplified cancer is selected from the group consisting of: breast, colon, endometrial, cervical, urothelial, lung (including, non-small cell lung cancer), ovarian, gastric, gastroesophageal junction (GEJ), head and neck, biliary tract, prostate, and pancreatic cancer. 13. The method of claim 11, wherein the refractory HER2-amplified cancer is metastatic. 14. The method of claim 11, wherein the refractory HER2-amplified cancer has a HER2:CEP17 ratio of 2.2-4.0 or >4.0. 15. The method of claim 11, wherein the refractory HER2-amplified cancer is refractory to a treatment of trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, or MM-111. 16. The method of claim 11, further comprising co-administering an additional therapeutic agent. 17. The method of claim 16, wherein the additional therapeutic agent is an anti-HER2 therapeutic agent, a pan-ErbB inhibitor, or an anti-VEGF therapeutic agent. 18. The method of claim 17, wherein the anti-HER2 therapeutic agent is selected from the group consisting of: trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, and MM-111. 19. The method of claim 17, wherein the pan-ErbB inhibitor is selected from the group consisting of: afatinib, neratinib, and dacomitinib. 20. The method of claim 17, wherein the anti-VEGF therapeutic agent is selected from the group consisting of: bevacizumab, ranibizumab, lapatinib, sunitinib, sorafenib, axitinib, and pazopanib. 21. The method of claim 16, wherein the additional therapeutic agent is selected from the group consisting of: temsirolimus; paclitaxel; varlitinib; vorinostat; doxorubicin; cyclophosphamide; cisplatin; docetaxel; dasatinib; trastuzumab and docetaxel; pertuzumab and docetaxel; doxorubicin, cyclophosphamide and paclitaxal; and doxorubicin, cyclophosphamide and fluorouracil.

Details for Patent 9,415,050

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2033-08-12
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2033-08-12
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-08-12