Prediction of Responsiveness to Treatment with Immunomodulatory Therapeutics and Method of Monitoring Abscopal Effects During Such Treatment
First Claim
1. A method for predicting efficacy of a therapeutic to enhance antitumor immunity in a patient, wherein the therapeutic is one that targets an immunomodulatory leukocyte membrane protein (ILMP) to enhance immune activity, comprising the step of determining pre-treatment levels of peripheral blood monocytes that are CD14+ and HLA-DRlow (PBM14+HLA-DRlow) in a blood sample from the patient , and comparing the determined pretreatment level to a discrimination threshold, wherein a level of PBM14+HLA-DRlow that is below the discrimination threshold indicate a likelihood of therapeutic efficacy.
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Abstract
Efficacy of a therapeutic to enhance antitumor immunity in a patient is predicted, where the therapeutic is one that targets an immunomodulatory leukocyte membrane protein (ILMP) to enhance immune activity. Peripheral blood sample from the patient is tested for levels of monocytes having specific cell surface markers (CD14+, HLA-DRlow) prior to treatment. Low levels of monocytes of this type (PBM14+HLA-DRlow) indicate a greater likelihood of therapeutic efficacy. In specific exemplary embodiments of the invention, the therapeutic is an antibody to CTLA4, such as ipilimumab or tremelimumab.
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Citations
32 Claims
- 1. A method for predicting efficacy of a therapeutic to enhance antitumor immunity in a patient, wherein the therapeutic is one that targets an immunomodulatory leukocyte membrane protein (ILMP) to enhance immune activity, comprising the step of determining pre-treatment levels of peripheral blood monocytes that are CD14+ and HLA-DRlow (PBM14+HLA-DRlow) in a blood sample from the patient , and comparing the determined pretreatment level to a discrimination threshold, wherein a level of PBM14+HLA-DRlow that is below the discrimination threshold indicate a likelihood of therapeutic efficacy.
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9-10. -10. (canceled)
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13-15. -15. (canceled)
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17. A method for treating a patient having a tumor that is responsive to a therapeutic, comprising the steps of performing a test to predict efficacy of a therapeutic to enhance antitumor immunity, in a patient, and administering the therapeutic to the patient if the test indicates a likelihood of therapeutic efficacy wherein said test to predict efficacy comprises the steps of
determining pre-treatment levels of peripheral blood monocytes that are CD14+ and HLA-DRlow (PBM14+HLA-DRlow) in a blood sample from the patient, and comparing the determined pretreatment level to a discrimination threshold, wherein a level of PBM14HLA-DRlow that is below the discrimination threshold indicate a likelihood of therapeutic efficacy.
- 18. A method for monitoring therapeutic progress of treatment with a therapeutic that targets an ILMP in combination with radiation therapy, comprising the steps of monitoring levels of PBM14+HLA-DRlow in the patient after treatment with the therapeutic and radiation, wherein decreases in PBM14+HLA-DRlow indicate therapeutic progress has or is about to commence.
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24-25. -25. (canceled)
Specification