Biomarkers for pre-selection of patients for anti-IGF1R therapy
AssigneeSchering Corporation
InventorsYan Wang, Jonathan Pachter, Yaolin Wang, Ming Liu
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Abstract
The present invention provides methods for identifying patients whose cancers are likely to be responsive to IGF1R inhibitory anti-cancer therapy along with methods for treating such patients. Patients identified by a method of the present invention can be treated with any of several known IGF1R inhibitory agents including antibodies, small molecule inhibitors and anti-sense nucleic acids.
Claims35
A method for treating a tumor in a patient with cancer comprising
- (a) selecting a patient or patient population having a tumor known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R;
- and
- (b) administering to said patient a therapeutically effective amount of an IGF1R inhibitory agent.
A method for treating a tumor in a patient with cancer comprising:
- (a) selecting a patient having a tumor expressing one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R;
- and
- (b) administering to said patient a therapeutically effective amount of an IGF1R inhibitory agent.
A method for selecting a therapy for a patient or a patient population with a tumor, comprising:
- (a) determining whether the patient's tumor is known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R;
- and
- (b) determining whether the patient's tumor expresses one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R;
- and
- (c) selecting an IGF1R inhibitory agent as the therapy if the patient's tumor is known to express one or more of (i)-(vi) and/or if the patient's tumor expresses one or more of (i)-(vi).
A method for advertising an IGF1R inhibitory agent or a pharmaceutically acceptable composition thereof comprising promoting, to a target audience, the use of the agent or pharmaceutical composition thereof for treating a patient or patient population whose tumors express or are known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R.
An article of manufacture comprising, packaged together, a pharmaceutical composition comprising an IGF1R inhibitory agent and a pharmaceutically acceptable carrier and a label stating that the agent or pharmaceutical composition is indicated for treating patients having a tumor expressing or known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R.
A method for manufacturing an IGF1R inhibitory agent or a pharmaceutical composition thereof comprising combining in a package the agent or pharmaceutical composition and a label stating that the agent or pharmaceutical composition is indicated for treating patients having a tumor expressing or known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R.
A method for identifying a patient whose tumor is likely to be responsive to an IGF1R inhibitory agent comprising:
- (a) determining whether the patient has a tumor known to express one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R;
- and/or
- (b) determining whether the patient has a tumor expressing one or more of the following:
- (i) IRS-1 phosphorylation on tyrosine 896;
- (ii) IRS-1 phosphorylation on tyrosine 612;
- (iii) IRS-1 phosphorylation on any tyrosine;
- (iv) IGF-II;
- (v) IGF1R phosphorylation on any tyrosine;
- or
- (vi) IGF1R.
Dependencies are inferred from the claim text.