Claims for Patent: 8,592,156

Summary for Patent: 8,592,156

Title:	Predicting response to anti-CD20 therapy in DLBCL patients
Abstract:	This invention provides methods, compositions, and kits relating to biomarkers whose expression levels are correlated with diffuse large B-cell lymphoma (DLCBL) patients\' response to treatment with a CD20 antagonist, such as a CD20 antibody, exemplified by rituximab. The methods, compositions, and kits of the invention can be used to identify DLBCL patients who are likely or not likely, to respond to anti-CD20 treatments.
Inventor(s):	Liu; Wei-min (Dublin, CA), Li; Yan (Palo Alto, CA), Lih; Chih-Jian (Gaithersburg, MD), Tai; Yu Chuan (Pleasanton, CA)
Assignee:	Roche Molecular Systems, Inc. (Pleasanton, CA)
Application Number:	13/205,469
Patent Claims:	1. A method of assessing a patient with diffuse large B-cell lymphoma (DLBCL), comprising: (a) obtaining a sample of the patient's tumor; and (b) determining in the sample the level of expression of a gene combination consisting of U2AF1, RNF2, ZC3H7B, CCNI, PSMD11, ABLIM1, GYG2, CAMK2G, NF1, SEQ ID NO: 1, TRIM66, FBXO21, MKNK2, FYTTD1, GET4, CABLES2, FMNL3, C22orf27, TBCEL, ZNF707, SEQ ID NO: 2, CSTB, BAHCC1, LOC723809, NPIP, gene coding for cDNA FLJ40566 fis clone THYMU2004733, LOC730367, RXFP2, MGC24125, SEQ ID NO: 3, PTP4A1, OSBP, HNRNPD, AHCYL1, BMP2K, IDS, SERPINB9, CSRP2BP, CD58, HERC4, MAGOH, TMBIM4, SFRS12, FAS, ZNF333, SEQ ID NO: 4, USP6, CHD6, LOC653160, SEQ ID NO: 5, SRPR, MIR21, ARHGAP18, SEQ ID NO:6, CBFA2T2, TIMP3, CTBS, USP16, RASA1 and YJEFN3. 2. The method of claim 1, wherein the patient is a candidate for anti-CD20 therapy. 3. The method of claim 2, wherein the anti-CD20 therapy is rituximab. 4. The method of claim 1, wherein the expression of the genes is measured by measuring the level of RNA transcribed from each gene. 5. The method of claim 1, further comprising determining the level of expression of the genes listed in step (b) in a control set of samples comprising a representative number of patients that exhibit response to anti-CD20 therapy and a representative number of patients that exhibit no response or poor response to anti-CD20 therapy. 6. The method of claim 1, wherein the level of expression is assessed using statistical methods. 7. A method of selecting a diffuse large B-cell lymphoma (DLBCL) patient for treatment with rituximab, comprising: (a) obtaining a sample of the patient's tumor; (b) detecting in the sample the expression of a gene combination consisting of U2AF1, RNF2, ZC3H7B, CCNI, PSMD11, ABLIM1, GYG2, CAMK2G, NF1, SEQ ID NO: 1, TRIM66, FBXO21, MKNK2, FYTTD1, GET4, CABLES2, FMNL3, C22orf27, TBCEL, ZNF707, SEQ ID NO: 2, CSTB, BAHCC1, LOC723809, NPIP, gene coding for cDNA FLJ40566 fis clone THYMU2004733, LOC730367, RXFP2, MGC24125, SEQ ID NO: 3, PTP4A1, OSBP, HNRNPD, AHCYL1, BMP2K, IDS, SERPINB9, CSRP2BP, CD58, HERC4, MAGOH, TMBIM4, SFRS12, FAS, ZNF333, SEQ ID NO: 4, USP6, CHD6, LOC653160, SEQ ID NO: 5, SRPR, MIR21, ARHGAP18, SEQ ID NO: 6, CBFA2T2, TIMP3, CTBS, USP16, RASA1 and YJEFN3; (c) comparing the expression determined in step (b) to the expression of the same genes in a control set of samples comprising a representative number of patients that exhibit response to rituximab therapy and a representative number of patients that exhibit no response or poor response to rituximab therapy to determine if the patient is likely to respond to rituximab; and (d) administering rituximab if the patient is determined likely to respond to rituximab.

Details for Patent 8,592,156

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-03-29
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-03-29
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2039-03-29