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Therapy Name | Azacitidine + Sabatolimab |
Synonyms | |
Therapy Description | |
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). |
Sabatolimab | MBG453|MBG-453|MBG 453 | Immune Checkpoint Inhibitor 149 TIM-3 Antibody 9 | Sabatolimab (MBG453) is monoclonal antibody that targets T-cell immunoglobulin and mucin domain-3 protein (TIM-3, HAVCR2), potentially resulting in enhanced anti-tumor immune response (PMID: 29544515, PMID: 31847708). |
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 |
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NCT04623216 | Phase Ib/II | Sabatolimab Azacitidine + Sabatolimab | Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. | Completed | ITA | FRA | ESP | DEU | 0 |
NCT04266301 | Phase III | Azacitidine Azacitidine + Sabatolimab | Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (STIMULUS-MDS2) | Completed | USA | TUR | NLD | LTU | LBN | ITA | ISR | GRC | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 15 |
NCT03946670 | Phase II | Decitabine + Sabatolimab Azacitidine Azacitidine + Sabatolimab Decitabine | A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). | Completed | USA | TUR | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | 4 |