Astellas Oncology
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A Selective Approach to R&D

Astellas Oncology pursues targeted therapies for hard-to-treat cancers with limited therapeutic options. Our pipeline includes novel compounds that focus on unmet medical needs.

Astellas Oncology Pipeline

Phase

Phase 3
Enzalutamide
Non-Metastatic Castration-
Resistant Prostate Cancer
MOA:
Androgen Receptor (AR) Inhibitor
NCT #: NCT02003924
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Enzalutamide
Non-Metastatic Biochemical Recurrent Prostate Cancer
MOA:
Androgen Receptor (AR) Inhibitor
NCT #: NCT02066961
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Enzalutamide
Metastatic Hormone-Sensitive Prostate Cancer
MOA:
Androgen Receptor (AR) Inhibitor
NCT #: NCT02677896
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Gilteritinib
Relapse/Refractory FLT3 Mutation-Positive Acute Myeloid Leukemia
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor
NCT #: NCT02421939
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Gilteritinib
Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Post-Stem Cell Transplant
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor
NCT #: NCT02997202
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Gilteritinib
Newly Diagnosed FLT3 Mutation- Positive Acute Myeloid Leukemia Post-High-Intensity Induction
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor
NCT #: NCT02927262
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Gilteritinib
Newly Diagnosed FLT3 Mutation- Positive Acute Myeloid Leukemia Not Eligible for High-Intensity Chemotherapy
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor
NCT #: NCT02752035
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Phase

Phase 2
Enzalutamide
Hepatocellular Carcinoma
MOA:
Androgen Receptor (AR) Inhibitor
NCT #: NCT02528643
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Blinatumomab
Non-Hodgkin Lymphoma
MOA:
Bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct
NCT #: NCT02811679
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Blinatumomab
Diffuse Large B-Cell Lymphoma
MOA:
Bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct
NCT #: NCT03023878
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Enfortumab vedotin
Metastatic Urothelial Cancer and Other Malignant Solid Tumors
MOA:
NECTIN-4 Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT02091999
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IMAB362
Gastroesophageal adenocarcinoma
MOA:
Cell Surface Antigen CLND18.2 Targeted Monoclonal Antibody
NCT #: NCT01630083
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AGS-16C3F
Metastatic Renal Cell Cancer
MOA:
Ectonucleotide Pyrophosphatase Phosphodiesterase 3 (ENPP3) Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT02639182
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Blinatumomab
Acute Lymphoblastic Leukemia
MOA:
Bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct
NCT #: NCT02412306
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Phase

Phase 1
ASG-15ME
Urothelial Cancer
MOA:
SLITRK6 Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT01963052
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AGS67E
Chronic Lymphocytic Leukemia / Prolymphocytic Leukemia / Non-Hodgkin Lymphoma / Hairy Cell Leukemia
MOA:
CD37 Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT02175433
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AGS67E
Acute Myeloid Leukemia
MOA:
CD37 Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT02610062
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AGS62P1
Acute Myeloid Leukemia
MOA:
FLT3 Targeted Antibody Drug Conjugate (ADC)
NCT #: NCT02864290
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ASP4132
Lymphoma and Solid Tumors
NCT #: NCT02383368
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GILTERITINIB
Newly Diagnosed Acute Myeloid Leukemia
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor1
NCT #: NCT02236013
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GILTERITINIB
Newly Diagnosed Acute Myeloid Leukemia (Japanese Patients)
MOA:
FMS-Like Tyrosine Kinase 3 (FLT3)/AXL Inhibitor1
NCT #: NCT02310321
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Immuno-Oncology R&D

Astellas Oncology and Potenza Therapeutics, Inc. are collaborating to advance a portfolio of immuno-oncology programs, including compounds with novel mechanisms of action targeting immune checkpoint pathways, co-stimulatory signals and regulatory T cells. First-generation, immuno-oncology products have shown meaningful benefit to patients with certain cancers; the goal of the Astellas Oncology/Potenza collaboration is to address the unmet medical need in patients who do not respond to existing treatments.

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