Methods and compositions for predicting response to eribulin
AssigneeEisai R&D Management Co., Ltd.
InventorsSergei I. Agoulnik, Michael Chapman Byrne, Bruce A. Littefield
Life of this patent
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Abstract
The invention provides methods for predicting the efficacy of eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof (e.g., eribulin mesylate), in the treatment of a subject suffering from breast cancer by determining the level of particular biomarkers in a sample derived from the subject.
Claims38
A method for determining whether eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, may be used to treat a subject having breast cancer, the method comprising
- (a) determining the level of expression of a biomarker selected from the group of biomarkers listed in Table 1 in a sample derived from said subject, wherein a low level of expression of the biomarker is indicative that eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, will be effective in treating said subject;
- or
- (b) assaying a sample derived from said subject to determine the level of expression in said sample of a biomarker selected from the group of biomarkers listed in Table 1, wherein a low level of expression of the biomarker is indicative that eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, will be effective in treating said subject.
(canceled)
A method for predicting whether eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, may be used to treat a subject having breast cancer, the method comprising
- determining the level of expression of a biomarker selected from the group of biomarkers listed in Table 1 in a sample derived from said subject, and
- predicting that eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, will be effective in treating a subject having breast cancer when said sample is determined to have a low level of expression of said biomarker.
A method for determining the sensitivity of a breast tumor to treatment with eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, the method comprising
- (a) determining the level of expression of a biomarker selected from the group of biomarkers listed in Table 1 in said tumor, wherein a low level of expression of the biomarker in said tumor indicates that said tumor is sensitive to treatment with eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof;
- or
- (b) determining the level of expression of a biomarker selected from the group of biomarkers listed in Table 1 in said tumor, and
- identifying said tumor as being sensitive to treatment with eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, when there is determined to be a low level of expression of said biomarker in said tumor.
(canceled)
A method of treating a subject having breast cancer, the method comprising
- (a) identifying a subject having breast cancer in which a biomarker selected from the group of biomarkers listed in Table 1 has a low level of expression, and administering a therapeutically effective amount of eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, to said subject;
- or
- (b) assaying a sample derived from said subject to determine the level of expression in said sample of a biomarker selected from the group of biomarkers listed in Table 1, and administering a therapeutically effective amount of eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, to said subject when a low level of expression of the biomarker is detected in said sample.
(canceled)
13-18. (canceled)
20-22. (canceled)
27-28. (canceled)
The method of claim 28, wherein the level of expression of said biomarker is determined by using a technique selected from the group consisting of an immunoassay, a western blot analysis, a radioimmunoassay, immunofluorimetry, immunoprecipitation, equilibrium dialysis, immunodiffusion, electrochemiluminescence immunoassay (ECLIA), ELISA assay, immunopolymerase chain reaction and combinations or sub-combinations thereof.
(canceled)
39-44. (canceled)
A kit for predicting whether eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, may be used to treat a subject having breast cancer, the kit comprising
- reagents for determining the level of expression of a biomarker selected from the group of biomarkers listed in Table 1;
- and
- instructions for use of the kit to predict whether eribulin, an analog thereof, or a pharmaceutically acceptable salt thereof, may be used to treat a subject having breast cancer.
49-50. (canceled)
(canceled)
Dependencies are inferred from the claim text.