Astex/Otsuka combo therapy hits goal in MDA or CMML

Japanese drugmaker Otsuka (TYO: 4578) and its US subsidiary Astex Pharmaceuticals have announce top-line results from the ASCERTAIN Phase III study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) versus decitabine IV in adults with intermediate and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML).

The study met its primary endpoint of decitabine exposure equivalence of five-day dosing between orally administered ASTX727 and IV decitabine as per the protocol analysis plan. Safety and clinical activity were similar to that observed in a previous Phase I/II study. The full data will be presented at an upcoming scientific meeting.

Astex plans to file a New Drug Application (NDA) with the US Food and Drug Administration by the end of 2019.