Predictive biomarkers for CTLA-4 blockade therapy and for PD-1 blockade therapy
AssigneeH. Lee Moffitt Cancer Center and Research Institute, Inc.
InventorsJeffrey S. Weber, Wenshi Wang, Bin Yu
Life of this patent
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Abstract
Biomarkers are described for predicting the efficacy, risk of relapse, risk of an immune related adverse event (irAE), or combination thereof for a CTLA-4 blockade treatment, such as ipilimumab, in a subject with melanoma. Biomarkers are also described for predicting the efficacy and clinical benefit for a PD-1 blockade treatment, such as a PD-1 blocking antibody, in a subject with melanoma.
Claims18
A method comprising assaying peripheral blood mononuclear cells (PBMCs) from a subject diagnosed with melanoma for expression of CD4, Ki67, and EOMES,
- wherein the frequency of Ki67+EOMES+CD4+ T cells in CD4+ T cells in the PBMCs is inversely proportional with the risk of an immune related adverse event (irAE) after CTLA-4 blockade treatment, and
- treating the subject with a CTLA-4 blockade treatment if the frequency of Ki67+EOMES+CD4+ T cells in PBMCs of the subject is at least 0.45%.
A method comprising
- assaying peripheral blood mononuclear cells (PBMCs) from a subject diagnosed with melanoma for expression of CD4, Ki67, and EOMES;
- and
- treating the subject with a treatment other than a CTLA-4 blockade treatment if the frequency of Ki67+EOMES+CD4+ T cells in PBMCs of the subject is less than 0.446%.
A method comprising
- assaying peripheral blood mononuclear cells (PBMCs) from a subject diagnosed with melanoma for expression of CD4, Ki67, and EOMES;
- and
- treating the subject with both a CTLA-4 blockade treatment and a different treatment if the frequency of Ki67+EOMES+CD4+ T cells in PBMCs of the subject is less than 0.446%.
A method comprising
- assaying peripheral blood mononuclear cells (PBMCs) from a subject diagnosed with melanoma for expression of CD4, Ki67, and EOMES,
- wherein the subject is treated with a CTLA-4 blockade treatment if the frequency of Ki67+EOMES+CD4+ T cells in PBMCs of the subject is at least 0.45%, and
- wherein the subject is not treated with a CTLA-4 blockade treatment if the frequency of Ki67+EOMES+CD4+ T cells in PBMCs of the subject is less than 0.446%.
A method of treating a subject diagnosed with melanoma comprising treating the subject with a CTLA-4 blockade treatment when the frequency of Ki67+EOMES+CD4+ T cells in assaying peripheral blood mononuclear cells (PBMCs) of the subject is at least 0.45%.
A method of treating a subject diagnosed with melanoma comprising treating the subject with a treatment other than a CTLA-4 blockade treatment if the measured frequency of Ki67+EOMES+CD4+ T cells in assaying peripheral blood mononuclear cells (PBMCs) of the subject is less than 0.446%.
A method of treating a subject diagnosed with melanoma comprising treating the subject with both a CTLA-4 blockade treatment and a different treatment if the measured frequency of Ki67+EOMES+CD4+ T cells in assaying peripheral blood mononuclear cells (PBMCs) of the subject is less than 0.446%.
Dependencies are inferred from the claim text.