Astex Pharmaceuticals announce results from the ASCERTAIN phase 3 study evaluating oral decitabine and cedazuridine fixed-dose combination (ASTX727 or DEC-C) tablets versus IV decitabine in adults with AML who are not candidates to receive standard induction chemotherapy.
The study met its primary endpoint of decitabine exposure equivalence of 5-day dosing between orally administered ASTX727 and intravenous (IV) decitabine as per the protocol analysis plan with a high degree of confidence. Safety observations were similar to those observed with IV decitabine.
The full data will be presented on June 10 as part of EHA2022. Astex plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and similar applications in other countries where IV decitabine is indicated for the treatment of AML.
Based on the data from the ASCERTAIN clinical program, the oral decitabine and cedazuridine fixed-dose combination is also being investigated in combination with other agents in hematological malignancies. The first of these studies is investigating the all-oral combination of decitabine and cedazuridine with venetoclax for the treatment of AML.
Oral decitabine and cedazuridine fixed-dose combination is approved as INQOVI® in the U.S. and Canada for the treatment of intermediate and high-risk myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) and is the only approved oral hypomethylating agent that has demonstrated equivalent exposure to its IV form.