Claims for Patent: 8,597,654

Summary for Patent: 8,597,654

Title:	Adjuvant therapy with an anti-ERBB2 antibody conjugated to a maytansiniod
Abstract:	The present application describes adjuvant therapy of nonmetastatic breast cancer using an anti-ErbB2 antibody conjugated to a maytansinoid.
Inventor(s):	Bryant; John L. (Allison Road, PA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	13/205,523
Patent Claims:	1. A method of adjuvant therapy comprising administering to a human subject having HER2 positive cancer, following definitive surgery, anthracycline cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and an effective amount of an immunoconjugate comprising an anti-ErbB2 antibody conjugated to a maytansinoid. 2. The method of claim 1, wherein the taxoid is paclitaxel or docetaxel. 3. The method of claim 1 wherein the anti-ErbB2 antibody specifically binds the extracellular domain of ErbB2. 4. The method of claim 3 wherein the anti-ErbB2 antibody specifically binds to the 4D5 epitope within the extracellular domain of ErbB2. 5. The method of claim 4 wherein the antibody is huMAb4D5-8. 6. The method of claim 5 wherein the maytansinoid is DM1 having the following structure ##STR00009## and wherein the antibody is chemically linked to the maytansinoid via a disulfide or thioether group at "R" shown in the structure. 7. The method of claim 5, wherein the immunoconjugate comprises from 3 to 5 maytansinoid molecules per antibody molecule. 8. The method of claim 5, wherein the antibody and the maytansinoid are conjugated by a chemical linker selected from N-succinimidyl-3-(2-pyridyldithio)propionate, N-succinimidyl-4-(2-pyridylthio)pentanoate (SPP) and succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC). 9. The method of claim 6 or 8, wherein the antibody and the maytansinoid are conjugated by succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate. 10. The method of claim 5, wherein the HER2 positive cancer is HER2 positive breast cancer. 11. The method of claim 1, claim 5, or claim 10, wherein said administration extends disease free survival (DFS) or overall survival (OS) in the subject. 12. The method of claim 10, wherein the HER2 positive cancer is nonmetastatic HER2 positive breast cancer. 13. The method of claim 10, wherein the immunoconjugate is administered in combination with an anti-ErbB2 antibody. 14. The method of claim 13, wherein the anti-ErbB2 antibody is a HER2 dimerization inhibitor. 15. The method of claim 14, wherein the HER2 dimerization inhibitor is pertuzumab.

Details for Patent 8,597,654

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409	06/08/2012		2025-05-13