Mohammad Azab, MD
The fixed-dose combination of cedazuridine and decitabine (ASTX727) demonstrated decitabine exposure equivalence of total 5-day dosing compared with intravenous (IV) decitabine in patients with intermediate- and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), meeting the primary endpoint of the phase III ASCERTAIN trial.
Additionally, safety and clinical activity of the combination were found to be similar to what had been observed in earlier phase I/II findings. Full findings will be presented at an upcoming medical meeting. The developer of cedazuridine, Astex Pharmaceuticals, which is a member of Ostuka, plans to file a new drug application for the combination by the end of 2019.
“We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed-dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of 5 days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years,” Mohammad Azab, president and chief medical officer, Astex Pharmaceuticals, said in a press release. “Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to this effort.”
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