Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study
Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination (ASTX727) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)
- Cedazuridine and decitabine, administered orally as a fixed-dose combination (ASTX727), met the primary endpoint of decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and IV decitabine in the phase 3 ASCERTAIN study in MDS and CMML patients
- The study confirmed that the safety profile and clinical activity of the cedazuridine and decitabine fixed-dose combination was similar to that observed in the phase 1/2 study and similar to the expected clinical profile of decitabine IV
- Astex plans to file a New Drug Application (NDA) with the US FDA by the end of 2019
- Astex is continuing to develop cedazuridine and decitabine fixed-dose combination in additional patient populations including those with acute myeloid leukemia (AML) and low-risk MDS
Pleasanton, CA and Tokyo, Japan - June 6th, 2019 - Astex Pharmaceuticals, Inc. a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) vs decitabine IV in adults with intermediate and high-risk MDS or CMML.
The study met its primary endpoint of decitabine exposure equivalence of 5-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 1/2 study. The full data will be presented at an upcoming scientific meeting.
Astex plans to file a NDA with the US FDA 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 five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years,” said Mohammad Azab, Astex Pharmaceuticals’ president and chief medical officer. “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.”
About Astex Pharmaceuticals, and Otsuka Pharmaceutical
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
For more information about Astex Pharmaceuticals, please visit: http://www.astx.com
For more information about Otsuka Pharmaceutical, please visit: http://www.otsuka.com/en/
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Astex Pharmaceuticals, Inc.
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