Claims for Patent: 9,109,255

Summary for Patent: 9,109,255

Title:	Methods and compositions for determining responsiveness to antibody therapy
Abstract:	Methods and compositions are provided for determining whether a subject suffering from a neoplastic condition is responsive to an antineoplastic therapy, such as antibody therapy, e.g., Rituximab. In practicing the subject methods, the subject is genotyped to determine whether the subject has a least one favorable Fc.gamma.R polymorphism, e.g., the 131 H/H genotype or the 158 V/V genotype. In addition, reagents, devices and kits thereof, that find use in practicing the subject methods are provided.
Inventor(s):	Levy; Ronald (Stanford, CA), Weng; Wen-Kai (Saratoga, CA)
Assignee:	The Board of Trustees of the Leland Stanford Junior University (Stanford, CA)
Application Number:	11/155,308
Patent Claims:	1. A method of treating a human subject suffering from non-Hodgkin's lymphoma (NHL) comprising: (a) obtaining a nucleic acid sample from the subject; (b) detecting in said nucleic acid the presence of a Fc.gamma.RIIa H/H genotype; (c) correlating the presence of said Fc.gamma.RIIa H/H genotype with an increased likelihood of responsiveness to IgG anti-CD20 antibody treatment; and (d) treating said subject with administration of an IgG anti-CD20 antibody. 2. The method of claim 1, wherein the method further comprises identifying a Fc.gamma.RIIIa 158 polymorphism result for the subject, wherein the Fc.gamma.RIIIa polymorphism result is a 158 V/V, 158 V/F, or 158 F/F genotype. 3. The method of claim 2, wherein identification of the Fc.gamma.RIIIa 158 VN genotype indicates an increased likelihood of responsiveness to said IgG anti-CD20 antibody as compared to a 158 F carrier genotype. 4. The method of claim 1, wherein said NHL is follicular lymphoma. 5. The method of claim 1, wherein said IgG anti-CD20 antibody is a monoclonal antibody. 6. The method of claim 5, wherein said monoclonal antibody is rituximab. 7. The method of claim 1, wherein the correlating comprises comparing the detected Fc.gamma.RIIa H/H genotype to a Fc.gamma.RIIa genotype control. 8. The method of claim 7, wherein said Fc.gamma.RIIa genotype control is a therapy responsive control. 9. The method of claim 8, wherein the therapy responsive Fc.gamma.RIIa genotype control is the Fc.gamma.RIIa 131 H/H genotype. 10. The method of claim 1, further comprising determining for said subject a probability of progression-free survival. 11. The method of claim 1, wherein said IgG anti-CD20 antibody promotes antibody-dependent cell cytotoxicity (ADCC). 12. The method of claim 1, wherein said detecting comprises amplifying a portion of the Fc.gamma.RIIa gene sequence comprising nucleic acids encoding amino acid residue 131 from the nucleic acid sample.

Details for Patent 9,109,255

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2024-06-18
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2024-06-18
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2024-06-18