Methods for treating multiple myeloma and the use of companion biomarkers for 4-(4-(4-(((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-4-yl)oxy)methyl)benzyl)piperazin-1-yl)-3-fluorobenzonitrile

Patent metadata

Field	Value
Publication number	US-2021181184-A1
Application number	US-202117173176-A
Country	US
Kind code	A1
Filing date	Feb 10, 2021
Priority date	May 23, 2018
Publication date	Jun 17, 2021
Grant date	—

Abstract

A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising administering the treatment compound to the subject having the cancer; obtaining a sample from the subject; determining the level of a biomarker in the sample from the subject; and diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample of the subject changes as compared to a reference level of the biomarker; wherein the treatment compound is Compound 1, Compound 2, or Compound 3.

First claim

What is claimed is:

1 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) administering the treatment compound to the subject; (b) obtaining a sample from the subject; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 1:

or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

2 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) administering the treatment compound to the subject; (b) obtaining a sample from the subject; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 2:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

3 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) administering the treatment compound to the subject; (b) obtaining a sample from the subject; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 3:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

4 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) obtaining a sample from the subject; (b) administering the treatment compound to the sample; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 1:

or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

5 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) obtaining a sample from the subject; (b) administering the treatment compound to the sample; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 2:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

6 . A method of identifying a subject having cancer who is likely to be responsive to a treatment compound, comprising:
(a) obtaining a sample from the subject; (b) administering the treatment compound to the sample; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; wherein the treatment compound is Compound 3:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

7 . The method of claim 1 - 3 or 4 - 6 , wherein the level of the biomarker in the sample is higher than the reference level of the biomarker.

8 . The method of claim 1 - 3 or 4 - 6 , wherein the level of the biomarker in the sample is lower than the reference level of the biomarker.

9 . A method of treating cancer, comprising:
(a) obtaining a sample from a subject having the cancer; (b) determining the level of a biomarker in the sample; (c) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; and (d) administering a therapeutically effective amount of the treatment compound to the subject diagnosed as being likely to be responsive to the treatment compound; wherein the treatment compound is Compound 1:

or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

10 . A method of treating cancer, comprising:
(a) obtaining a sample from a subject having the cancer; (b) determining the level of a biomarker in the sample; (c) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; and (d) administering a therapeutically effective amount of the treatment compound to the subject diagnosed as being likely to be responsive to the treatment compound; wherein the treatment compound is Compound 2:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

11 . A method of treating cancer, comprising:
(a) obtaining a sample from a subject having the cancer; (b) determining the level of a biomarker in the sample; (c) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from a reference level of the biomarker; and (d) administering a therapeutically effective amount of the treatment compound to the subject diagnosed as being likely to be responsive to the treatment compound; wherein the treatment compound is Compound 3:

or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof.

12 . The method of claims 9 - 11 , wherein the level of the biomarker in the sample is higher than the reference level of the biomarker.

13 . The method of claims 9 - 11 , wherein the level of the biomarker in the sample is lower than the reference level of the biomarker.

14 . A method of predicting the responsiveness of a subject having or suspected of having cancer to a treatment compound, comprising:
(a) administering the treatment compound to the subject; (b) obtaining a sample from the subject; (c) determining the level of a biomarker in the sample; and (d) diagnosing the subject as being likely to be responsive to the treatment compound if the level of the biomarker in the sample is different from the level of the biomarker obtained from a reference sample; whe

Assignees

• Celgene Corp

Inventors

• Anton Maria Soraya Carrancio
• Hansen Joshua
• Havens Courtney G
• Lopez-Girona Antonia
• Lu Gang
• Pierce Daniel W
• Wong Lilly L

Classifications

• G01N33/5758

  involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites · CPC title

• G01N33/57505 Primary

  of the blood, e.g. leukaemia · CPC title

• A61P35/02

  specific for leukemia · CPC title

• G01N33/6869

  Interleukin · 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