Claims for Patent: 8,652,479

Summary for Patent: 8,652,479

Title:	Antibody-drug conjugates and methods
Abstract:	The present invention relates to antibody-drug conjugate compounds of Formula I: Ab-(L-D).sub.p I where one or more maytansinoid drug moieties (D) are covalently linked by L to an antibody (Ab) which binds to an ErbB receptor, or which binds to one or more tumor-associated antigens or cell-surface receptors. These compounds may be used in methods of diagnosis or treatment of cancer, and other diseases and disorders.
Inventor(s):	Ebens, Jr.; Allen J. (San Carlos, CA), Jacobson; Frederic S. (Berkeley, CA), Polakis; Paul (Burlingame, CA), Schwall; Ralph H. (Pacifica, CA), Sliwkowski; Mark X. (San Carlos, CA), Spencer; Susan D. (Tiburon, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	12/052,938
Patent Claims:	1. A method of treating breast cancer comprising administering to a patient a formulation of trastuzumab-SMCC-DM1 and a pharmaceutically acceptable diluent, carrier or excipient, in combination with lapatinib; wherein trastuzumab-SMCC-DM1 has the structure: ##STR00024## and p is 1 to 8; the breast cancer overexpresses ErbB2 at a 2+level or more; and the patient is administered a dose of 3 to 10 mg/kg of trastuzumab-SMCC-DM1 by infusion about every 7 to about every 21 days. 2. The method of claim 1 wherein trastuzumab-SMCC-DM1 is formulated with a pharmaceutically acceptable parenteral vehicle. 3. The method of claim 1 wherein the formulation comprises about 10 to 30 mg per ml of trastuzumab-SMCC-DM1. 4. The method of claim 3 wherein the formulation comprises about 20 mg per ml of trastuzumab-SMCC-DM1. 5. The method of claim 1 wherein the formulation comprises up to 10% molar equivalent of DM1-SMCC. 6. The method of claim 1 wherein the pharmaceutically acceptable diluent, carrier or excipient is selected from one or more of succinate, polysorbate 20, and trehalose. 7. The method of claim 1 further comprising measuring thrombocytopenia. 8. The method of claim 7 further comprising the step of adjusting the dose of trastuzumab-SMCC-DM1 to the patient to lessen thrombocytopenia. 9. The method of claim 1 wherein the formulation of trastuzumab-SMCC-DM1 and lapatinib are administered sequentially. 10. The method of claim 1 wherein the formulation of trastuzumab-SMCC-DM1 and lapatinib are coadministered in separate formulations. 11. The method of claim 1 wherein the formulation of trastuzumab-SMCC-DM1 and lapatinib are coadministered in a single formulation. 12. The method of claim 1 wherein the patient failed to respond or responded poorly to prior HERCEPTIN.RTM.treatment.

Details for Patent 8,652,479

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2024-06-01
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2024-06-01
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2024-06-01