- Clinical Pipeline
- Guadecitabine (SGI-110) DNMT inhibitor (Hematological Malignancies and Solid Tumors)
- ASTX029 Extracellular Signal-Related Protein Kinases (ERK 1/2) Inhibitor (Solid Tumors)
- Oral Decitabine and Cedazuridine (ASTX727) (Hematological Malignancies)
- ASTX660 Dual IAP Antagonist (Solid Tumors & Lymphomas)
- ASTX295 Oral Murine Double Minute 2 (MDM2) antagonist (Solid Tumors)
- Partnered Products and Programs
- Kisqali®(ribociclib) CDK4/6 inhibitor (Oncology)
- Balversa® (erdafitinib) FGFr inhibitor (Oncology)
- AZD5363 PKB/Akt Inhibitor (Oncology)
- Multiple Targets and Therapeutic Areas
- Pyramid™ Discovery Platform
- Oncology and CNS Discovery
- Sustaining Innovation
|Phase 1||Phase 2||Phase 3|
Oral Decitabine and Cedazuridine (ASTX727)
DNA methyltransferase (DNMT) inhibitor (Hematological Malignancies)
Mechanism of Action: DNA methyltransferase (DNMT) inhibition
Indication: Hematological Malignancies
How this therapy can help
Oral decitabine and cedazuridine (ASTX727) is a unique fixed-dose combination of the hypomethylating agent decitabine, the active ingredient in Dacogen®, and the novel cytidine deaminase inhibitor, E7727 (cedazuridine). Oral decitabine and cedazuridine was designed to deliver decitabine by oral administration. By inhibiting cytidine deaminase, cedazuridine inhibits the major mechanism by which decitabine is degraded in the gut and liver, and the combination therefore permits the efficient delivery of decitabine orally.
Astex has completed a Phase 3 clinical study of oral decitabine and cedazuridine in treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML), the ASCERTAIN study. This study was a multicenter, randomized, open-label, crossover PK study of oral decitabine and cedazuridine versus IV decitabine. The ASCERTAIN study has been expanded to include enrollment of acute myeloid leukemia (AML) patients in the European Union (EU).
Astex is developing a low-dose formulation of oral decitabine and cedazuridine for the treatment of chronic conditions where oral delivery of a hypomethylating agent would be preferred. These include lower-risk MDS, and in AML maintenance following intensive chemotherapy.
Oral decitabine and cedazuridine is also being studied in combination with tolinapant (ASTX660) in the treatment of AML.