Abstract: The present invention is directed to a method of treating a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), including hematologic malignancies that are refractive to chemotherapeutic and/or hypomethylating agents. The method concerns administering a CD123×CD3 bispecific binding molecule to a patient in an amount effective to stimulate the killing of cells of said hematologic malignancy in said patient. The present invention is particularly directed to the embodiment of such method in which a cellular sample (Z from the patient prior to such administration evidences an expression of one or more target genes that is increased relative to a baseline level of expression of such genes, for example, a baseline level of expression of such genes in a reference population of individuals who are suffering from the hematologic malignancy, or with respect to the level of expression of a reference gene.

Abstract: The present invention is directed to a dosing regimen for administering a CD 123×CDS bispecific diabody to patients with a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The present invention is also directed to a dosing regimen for administering a CD 123×CDS bispecific diabody in combination with a molecule capable of binding PD-1 or a natural ligand of PD-1 (a “PD-1 or PD-1 ligand binding molecule”) to patients with a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The invention particularly concerns the use of such regimens for administering the sequence-optimized CD 123×CDS bispecific diabody, “DART-A,” which is capable of simultaneous binding to CD 123 and CDS.

Abstract: The present invention is directed to a method of treating a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), including hematologic malignancies that are refractive to chemotherapeutic and/or hypomethylating agents. The method concerns administering a CD123×CDS bispecific binding molecule to a patient in an amount effective to stimulate the killing of cells of said hematologic malignancy in said patient. The present invention is additionally directed to the embodiment of such method in which a cellular sample from the patient evidences an expression of one or more target genes that is increased relative to a baseline level of expression of such genes, for example, a baseline level of expression of such genes in a reference population of individuals who are suffering from the hematologic malignancy, or with respect to the level of expression of a reference gene.