Astex Reports Results of Decitabine and Cedazuridine (ASTX727 or DEC-C) in P-III (ASCERTAIN) Trial as Fixed-Dose Combination for Acute Myeloid Leukemia

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The P-III (ASCERTAIN) study evaluates decitabine + cedazuridine (ASTX727 or DEC-C) as a fixed-dose combination vs IV decitabine in adults with AML
The study met its 1EPs i.e., the combination provides exposure equivalence to IV decitabine at 5-day dosing, and safety results were similar to IV decitabine. The results will be presented at EHA 2022 in Vienna, Austria
The company intends to submit an MAA to EMA & equivalent applications in other countries where IV decitabine is used to treat AML. The oral combination is being studied for hematological malignancies in combination with other agents & was approved as Inqovi in the US & Canada for intermediate and high-risk MDS including CMML

Ref: Businesswire | Image: Astex

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