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AssigneeAmgen Inc.
InventorsSophia K. Khaldoyanidi, Dirk Nagorsen, Tara Arvedson, Suresh Agarwal, Vijay Vishesh Upreti, Steven Yea
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The present invention relates to medical combination products comprising (i) at least one antibody construct comprising at least one domain which binds to a target antigen expressed on the surface of a cell and at least one other domain which binds to CD3 as well as (ii) at least one molecule that is inhibitor/antagonist of TNF/TNFR reducing TNF/TNFR signaling and/or an inhibitor/antagonist of IL6/IL6R that reduces IL6/IL6R signaling, wherein a first dose of said inhibitor/antagonist is administered before administration of a first dose of said antibody construct. Furthermore, the invention provides therapeutic and preventive methods and medical uses of said combination products, as well as a kit comprising said at least one antibody construct and at least one antagonist/inhibitor of TNF or IL6 or its cognate receptor, wherein the interaction of said antagonist/inhibitor of TNF or an inhibitor/antagonist of IL6 with its cognate receptor reduces, mitigates, prevents, or treats cytokine release syndrome.
A method for the treatment of a disease, particularly cancer and/or for the prophylaxis, prevention, reduction, amelioration, and/or alleviation of adverse events associated with cancer immunotherapy, particularly with cancer immunotherapy engaging T cells via CD3 binding antibody constructs in a human patient, said method comprising
The method of any one of the preceding claims, further comprising administering at least one corticosteroid and/or a non-glucocorticoidal compound.
The method of any one of the preceding claims, wherein said corticostoid is dexamethasone, and/or said non-glucocorticoidal compound is selected from the group comprising natalizumab, PPS, and minocylin.
The method of any one of the preceding claims, wherein said patient is selected from the group of patients at risk of developing adverse events or having an intolerance to corticosteroids, optionally also wherein the corticosteroid is dexamethasone.
The method of any one of the preceding claims, wherein the step of administering an antibody construct that binds selectively to a target antigen on a cancer cell and to human CD3 on the surface of a T cell is the first exposure of said antibody construct.
Dependencies are inferred from the claim text.