Claims for Patent: 9,017,671

Summary for Patent: 9,017,671

Title:	Method of treating cancer with a pharmaceutical formulation comprising a HER2 antibody
Abstract:	The present application describes antibody formulations, including monoclonal antibodies formulated in histidine-acetate buffer, as well as a formulation comprising an antibody that binds to domain II of HER2 (for example, Pertuzumab), and a formulation comprising an antibody that binds to DR5 (for example, Apomab).
Inventor(s):	Andya; James (Millbrae, CA), Gwee; Shiang C. (Pacifica, CA), Liu; Jun (Pacifica, CA), Shen; Ye (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	13/660,114
Patent Claims:	1. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering a pharmaceutical formulation to the subject in an amount effective to treat the cancer, wherein the formulation comprises an antibody that binds to domain II of HER2 in a histidine-acetate buffer at a pH from about 5.5 to about 6.5, a saccharide, and a surfactant. 2. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering a pharmaceutical formulation to the subject in an amount effective to treat the cancer, wherein the formulation comprises an antibody that binds to domain II of HER2 in a histidine-acetate buffer at a pH from about 5.5 to about 6.5, a saccharide, and a surfactant, wherein the antibody concentration is from 20mg/mL to 40mg/mL, the antibody comprises the variable light and variable heavy amino acid sequences in SEQ ID Nos. 3 and 4, respectively, the saccharide is sucrose at a concentration from about 60mM to about 250mM, and the surfactant is polysorbate 20 at a concentration from about 0.01% to about 0.1%. 3. The method of claim 2 wherein the HER2 antibody comprises a light chain amino acid sequence selected from SEQ ID No. 15 and 23, and a heavy chain amino acid sequence selected from SEQ ID No. 16 and 24. 4. The method of claim 2 wherein the pH of the formulation is from about 5.8 to about 6.2. 5. The method of claim 2 wherein the antibody binds to the junction between domains I, II and III of HER2. 6. The method of claim 2 wherein the antibody is a full length antibody. 7. The method of claim 2 wherein the formulation is aqueous and has not been subjected to prior lyophilization. 8. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering a pharmaceutical formulation to the subject in an amount effective to treat the cancer, wherein the formulation comprises Pertuzumab in an amount from 20mg/mL to 40mg/mL, histidine-acetate buffer, sucrose, and polysorbate 20, wherein the pH of the formulation is from about 5.5 to about 6.5. 9. The method of claim 8 wherein the formulation comprises about 30mg/mL Pertuzumab, about 20mM histidine-acetate, about 120mM sucrose, and about 0.02% polysorbate 20, wherein the pH of the formulation is about 6.0. 10. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering a pharmaceutical formulation to the subject in an amount effective to treat the cancer, wherein the formulation is an aqueous pharmaceutical formulation which has not been subjected to prior lyophilization, comprising about 30mg/mL Pertuzumab, about 20mM histidine-acetate, about 120mM sucrose, and about 0.02% polysorbate 20, wherein the pH of the formulation is about 6.0. 11. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering to the subject an aqueous pharmaceutical formulation which has not been subjected to prior lyophilization in an amount effective to treat the cancer, wherein the formulation comprises an antibody that binds to domain II of HER2 in a histidine-actetate buffer at a pH from about 5.5 to about 6.5, a saccharide, and a surfactant. 12. The method of claim 11 wherein the antibody is a full length IgG1 antibody. 13. A method of treating HER2-expressing cancer in a subject, comprising intravenously administering to the subject an aqueous pharmaceutical formulation which has not been subjected to prior lyophilization in an amount effective to treat the cancer, wherein the formulation comprises an antibody comprising the variable light and variable heavy amino acid sequences in SEQ ID Nos. 3 and 4, respectively, in a histidine-acetate buffer at a pH from about 5.5 to about 6.5, a saccharide, and a surfactant. 14. The method of claim 13 wherein the antibody is a full length IgG1 antibody.

Details for Patent 9,017,671

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409	06/08/2012		2024-10-20