Therapy Detail

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Therapy Name Azacitidine + Durvalumab
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).
Durvalumab Imfinzi MEDI4736 Immune Checkpoint Inhibitor 148 PD-L1/PD-1 antibody 117 Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02117219 Phase I Azacitidine + Durvalumab Phase 1 Study to Evaluate MEDI4736 in MDS Completed USA | GBR | FRA | DEU 0
NCT02775903 Phase II Azacitidine Azacitidine + Durvalumab An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Subjects With Acute Myeloid Leukemia (AML) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT 2
NCT02811497 Phase II Azacitidine + Durvalumab Study of Azacitidine and Durvalumab in Advanced Solid Tumors (METADUR) Completed CAN 0
NCT03161223 Phase Ib/II Durvalumab + Romidepsin Azacitidine + Durvalumab Azacitidine + Durvalumab + Romidepsin Durvalumab + Pralatrexate + Romidepsin Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma Unknown status USA 0
NCT02281084 Phase II Azacitidine Azacitidine + Durvalumab Safety and Efficacy Study of CC-486 and Durvalumab in Subjects With Myelodysplastic Syndromes Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 1


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