RNF41 as a biomarker predicting response to lenalidomide in non-del(5q) MDS

Patent metadata

Field	Value
Publication number	US-10612097-B2
Application number	US-201715682062-A
Country	US
Kind code	B2
Filing date	Aug 21, 2017
Priority date	Dec 5, 2012
Publication date	Apr 7, 2020
Grant date	Apr 7, 2020

Abstract

Disclosed herein is a method of using erythroid expression levels of RNF41 as a predictive biomarker for responsiveness to lenalidomide (LEN) in patients with non-del(5q) MDS.

First claim

What is claimed is:

1. A method for treating a subject with non-del(5q) myelodysplastic syndrome (MDS), comprising
a) measuring expression levels of Ring Finger Protein 41 (RNF41) in erythroid cells in a sample from the subject prior to treatment for MDS, and
b) administering to the subject a therapeutically effective dose of lenalidomide (LEN), or a functional derivative thereof, if the levels of RNF41 are reduced compared to a control value established from one or more non-responders to LEN; or
administering an alternative therapy for the subject if the levels of RNF41 are elevated compared to a control value established from one or more responders to LEN.

2. The method of claim 1 , wherein the sample is a blood or bone marrow sample.

3. The method of claim 1 , wherein RNF41 protein expression levels are measured using an immunoassay comprising an antibody that specifically binds RNF41.

4. The method of claim 3 , wherein the immunoassay comprises enzyme-linked immunosorbent assay (ELISA), immunohistochemistry, or flow cytometery.

5. The method of claim 1 , wherein RNF41 gene expression levels are measured using one or more oligonucleotides that function as primers or probes for detecting RNF41 gene expression levels.

6. The method of claim 1 , comprising administering to the subject a therapeutically effective dose of LEN if mean levels of RNF41 in the subject sample are reduced by at least 10% compared to a value from a control sample from a known non-responder to LEN.

7. The method of claim 1 , comprising treating the subject with 5-azacitidine or decitabine if mean levels of RNF41 in the subject sample are elevated by at least 10% compared to a value from a control sample from a known responder to LEN.

8. The method of claim 1 , comprising treating the subject with 5-recombinant erythropoietins or antithymocyte globuli if mean levels of RNF41 in the subject sample are elevated by at least 10% compared to a value from a control sample from a known responder to LEN.

Assignees

• H Lee Moffitt Cancer Ct & Res

Inventors

• List Alan

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• G01N33/573 Primary

  for enzymes or isoenzymes · CPC title

• A61K31/454

  containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone · CPC title

• C12Q1/6883 Primary

  for diseases caused by alterations of genetic material · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title