Angiopoiten-2 biomarkers predictive of anti-immune checkpoint response
AssigneeDana-Farber Cancer Institute, Inc.
InventorsF. Stephen Hodi, Jun Zhou, Xinqi Wu
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Abstract
The present invention is based on the identification of novel biomarkers predictive of responsiveness to anti-immune checkpoint therapies.
Claims36
A method of identifying the likelihood of a cancer in a subject to be responsive to an anti-immune checkpoint therapy, the method comprising:
- a) obtaining or providing a patient sample from a patient having cancer;
- b) measuring the amount or activity of at least one biomarker listed in Table 1 in the subject sample;
- and
- c) comparing said amount or activity of the at least one biomarker listed in Table 1 in a control sample,
- wherein a significantly increased amount or activity of the at least one biomarker listed in Table 1 in the subject sample relative to the control sample identifies the cancer as being less likely to be responsive to the anti-immune checkpoint therapy and wherein a decreased amount or activity of the at least one biomarker listed in Table 1 in the subject sample relative to the control sample identifies the cancer as being more likely to be responsive to the anti-immune checkpoint therapy.
A method of identifying the likelihood of a cancer in a subject to be responsive to anti-immune checkpoint therapy, the method comprising:
- a) obtaining or providing a patient sample from a patient having cancer, wherein the sample comprises nucleic acid molecules from the subject;
- b) determining the copy number of at least one biomarker listed in Table 1 in the sample;
- and
- c) comparing said copy number to that of a control sample, wherein an increased copy number of the biomarker in the sample relative to the control sample identifies the cancer as being less likely to be responsive to the anti-immune checkpoint therapy and wherein a decreased copy number of the biomarker in the sample relative to the control sample identifies the cancer as being more likely to be responsive to the anti-immune checkpoint therapy.
A method of assessing the efficacy of an agent for treating a cancer in a subject that is unlikely to be responsive to anti-immune checkpoint therapy, comprising:
- a) detecting in a first subject sample and maintained in the presence of the agent the amount or activity of at least one biomarker listed in Table 1;
- b) detecting the amount or activity of the at least one biomarker listed in Table 1 in a second subject sample and maintained in the absence of the test compound;
- and
- c) comparing the amount or activity of the at least one biomarker listed in Table 1 from steps a) and b), wherein a significantly increased amount or activity of the at least one biomarker listed in Table 1 in the first subject sample relative to at least one subsequent subject sample, indicates that the agent treats the cancer in the subject.
A method of assessing the efficacy of an agent for treating a cancer in a subject or prognosing progression of a cancer in a subject, comprising:
- a) detecting in a subject sample at a first point in time the amount or activity of at least one biomarker listed in Table 1;
- b) repeating step a) during at least one subsequent point in time after administration of the agent;
- and
- c) comparing the expression and/or activity detected in steps a) and b), wherein a significantly increased amount or activity of the at least one biomarker listed in Table 1 in the first subject sample relative to at least one subsequent subject sample, indicates that the cancer is unlikely to progress or that the agent treats the cancer in the subject.
A cell-based assay for screening for agents that have a cytotoxic or cytostatic effect on a cancer cell that is unresponsive to anti-immune checkpoint therapy comprising, contacting the cancer cell with a test agent, and determining the ability of the test agent to decrease the amount or activity of at least one biomarker listed in Table 1.
The cell-based assay of claim 17, wherein the step of contacting occurs in vivo, ex vivo, or in vitro.
Dependencies are inferred from the claim text.