Claims for Patent: 7,811,562

Summary for Patent: 7,811,562

Title:	Biomarkers for pre-selection of patients for anti-IGF1R therapy
Abstract:	The present invention provides methods for identifying patients whose cancers are likely to be responsive to IGF1R inhibitory anti-cancer therapy along with methods for treating such patients. Patients identified by a method of the present invention can be treated with any of several known IGF1R inhibitory agents including antibodies, small molecule inhibitors and anti-sense nucleic acids.
Inventor(s):	Wang; Yan (Scotch Plains, NJ), Pachter; Jonathan A. (Setauket, NY), Wang; Yaolin (Edison, NJ), Liu; Ming (Fanwood, NJ)
Assignee:	Schering Corporation (Kenilworth, NJ)
Application Number:	11/290,687
Patent Claims:	1. A method for treating a non-small cell lung tumor, an ovarian tumor, a neuroblastoma tumor or an osteosarcoma tumor in a mammalian patient wherein growth or survival of the tumor is mediated by IGF1R expression or activity said method comprising: (a) selecting a mammalian patient having a non-small cell lung tumor, an ovarian tumor, a neuroblastoma tumor or an osteosarcoma tumor expressing phosphorylated IRS-1 tyrosine 896 or phosphorylated IRS-1 tyrosine 612; and (b) administering to said mammalian patient a therapeutically effective amount of an isolated antibody that binds specifically to IGF1R comprising a light chain immunoglobulin variable domain comprising the amino acid sequence: EIVLTQSPGT LSVSPGERATLSCRASQSIGSSLHWYQQKPGQAPRLLIKYASQSLSGIPD RFSGSGSGTDFTLTISRLEPEDFAVYYCHQSSRLPHTFGQGTKVEIKRT (amino acids 20-128 of SEQ ID NO: 8); and a heavy chain immunoglobulin variable domain comprising the amino acid sequence: EVQLVQSGGGLVKPGGSLRLSCAASGFTFSSFAMHWVRQAPGKGLEWISVIDTRGATYYA DSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARLGNFYYGMDVWGQGTTVTVSS (amino acids 20-137 of SEQ ID NO: 10); wherein said antibody inhibits growth or survival of said tumor. 2. The method of claim 1 wherein the tumor is an osteosarcoma tumor. 3. The method of claim 2 wherein the antibody is a monoclonal antibody and the patient is a human. 4. The method of claim 2 wherein the antibody is a fully human monoclonal antibody and the patient is a human. 5. The method of claim 3 wherein said light chain immunoglobulin variable domain is conjugated to an immunoglobulin kappa constant domain and said heavy chain immunoglobulin variable domain is conjugated to an immunoglobulin gamma 1 constant domain. 6. The method of claim 4 wherein said light chain immunoglobulin variable domain is conjugated to an immunoglobulin kappa constant domain and said heavy chain immunoglobulin variable domain is conjugated to an immunoglobulin gamma 1 constant domain. 7. The method of claim 3 wherein said patient is administered the monoclonal antibody in association with one or more additional anti-cancer agents. 8. The method of claim 7 wherein the patient is administered said monoclonal antibody in association with one or more additional anti-cancer agents selected from the group consisting of: paclitaxel, thalidomide, docetaxel, gefitinib, temozolomide, lonafarnib, tipifarnib, letrozole, doxorubicin, cis-platin, oxaliplatin, camptothecin, topotecan, etoposide, vincristine, vinblastine, raloxifene, gemcitabine, retinoic acid, tamoxifen, trastuzumab, cetuximab and octreotide. 9. The method of claim 4 wherein said patient is administered the monoclonal antibody in association with one or more additional anti-cancer agents. 10. The method of claim 9 wherein the patient is administered said monoclonal antibody in association with one or more additional anti-cancer agents selected from the group consisting of: paclitaxel, thalidomide, docetaxel, gefitinib, temozolomide, lonafarnib, tipifarnib, letrozole, doxorubicin, cis-platin, oxaliplatin, camptothecin, topotecan, etoposide, vincristine, vinblastine, raloxifene, gemcitabine, retinoic acid, tamoxifen, trastuzumab, cetuximab and octreotide. 11. The method of claim 8 wherein the additional anti-cancer agent is paclitaxel. 12. The method of claim 8 wherein the additional anti-cancer agent is docetaxel. 13. The method of claim 8 wherein the additional anti-cancer agent is gefitinib. 14. The method of claim 8 wherein the additional anti-cancer agent is cis-platin. 15. The method of claim 8 wherein the additional anti-cancer agent is oxaliplatin. 16. The method of claim 8 wherein the additional anti-cancer agent is octreotide.

Details for Patent 7,811,562

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2024-12-03
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2024-12-03
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2024-12-03
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2024-12-03