Therapy Detail
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| Therapy Name | Azacitidine + Hu5F9-G4 |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
| Hu5F9-G4 | Magrolimab|Hu5F9 G4|GS-4721 | CD47 Antibody 30 Immune Checkpoint Inhibitor 147 | Magrolimab (Hu5F9-G4) is a humanized monoclonal antibody against CD47 that binds to and blocks CD47 downstream signaling and subsequent activation of the SIRPa receptor on macrophages, leading to phagocytosis of tumor cells (PMID: 26390038, PMID: 28286286) and may also stimulate cytotoxic T-cells (PMID: 29873856). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 mutant | acute myeloid leukemia | predicted - sensitive | Azacitidine + Hu5F9-G4 | Phase I | Actionable | In a Phase Ib trial, Magrolimab (Hu5F9-G4) and Vidaza (azacitidine) combination therapy was well tolerated, and resulted in complete response in 42% (5/12), complete response with incomplete hematologic recovery in 33% (4/12), and stable disease in 17% (2/12) of patients with acute myeloid leukemia harboring TP53 mutations and unfit for chemotherapy (J Clin Oncol 38: 2020 (suppl; abstr 7507); NCT03248479). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03248479 | Phase I | Azacitidine + Hu5F9-G4 Hu5F9-G4 | Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies | Terminated | USA | GBR | 0 |
| NCT04313881 | Phase III | Azacitidine Azacitidine + Hu5F9-G4 | Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) (ENHANCE) | Terminated | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 9 |
| NCT04778397 | Phase III | Cytarabine + Idarubicin Azacitidine + Venetoclax Azacitidine + Hu5F9-G4 Cytarabine + Daunorubicin | Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated (ENHANCE-2) | Terminated | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 5 |
| NCT04778410 | Phase II | Azacitidine + Hu5F9-G4 + Venetoclax Cytarabine + Etoposide + Hu5F9-G4 + Mitoxantrone Azacitidine + Hu5F9-G4 | Study of Magrolimab Combinations in Participants With Myeloid Malignancies | Completed | USA | GBR | AUS | 0 |
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