Abstract: A method for estimating tumor growth dynamics includes obtaining, by one or more processors, progression-free survival (PFS) data for a plurality of patients, the PFS data indicating (i) a plurality of observation times, and (ii) how many of the plurality of patients, at each of the plurality of observation times, had a PFS event within a most recent time window; determining, by the one or more processors and based on the PFS data, a population distribution for one or more patient-specific parameters; obtaining, by the one or more processors, measured tumor growth data for a particular patient subject to a drug treatment; estimating, by the one or more processors, tumor growth for the particular patient based on (i) the measured tumor growth data and (ii) the population distribution for the one or more patient-specific parameters; and causing, by the one or more processors, a display to present a visual indication of the estimated tumor growth for the particular patient.

Abstract: The present invention provides a method for the treatment of DLL3-positive cancer or SCLC, comprising administering to a subject in need thereof an anti-DLL3 agent at a dose of between about 0.3 mg to about 100 mg or between about 3 mg to about 200 mg, once every two weeks. Step dosing of the anti-DLL3 agent for the treatment of SCLC is also disclosed.

Abstract: 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.

Abstract: The present invention relates to the dosage and administration of anti-BCMA agents for the treatment of BCMA positive neoplasms. More specifically, the present invention relates to an antibody construct comprising a first domain which binds to BCMA, a second domain which binds to CD3 and a third domain which extends or enhances the half-life of the antibody construct, for use in the treatment or amelioration of a BCMA positive neoplasm, wherein the antibody construct is administered at a specified dose in at least one cycle. Moreover, the invention relates to a method for the treatment of a BCMA positive neoplasm comprising administering a specified dose of such antibody construct, and the use of such antibody construct for the manufacture of a medicament for the treatment of a BCMA positive neoplasm.