DTMT Network

Atex Pharmaceuticals has recently announced that its oral combination drug for treating acute leukaemia has met its primary endpoint during the Phase-3 trial.

In a statement, the company said that its oral decitabine and cedazuridine fixed-dose combination (ASTX727), may offer a treatment alternative to patients with acute leukaemia, where they can take the drug at home as opposed to visiting clinics and hospitals, where they need to visit currently to get decitabine IV infusion.

During the trial, the oral fixed-dose combination in adult patients with AML, not candidates for standard induction chemotherapy demonstrated decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and intravenous (IV) decitabine, the statement added.

 Atex informed that it will present the data of the trial on June 10, 2022, during the EHA2022 Congress scheduled to be held in Vienna from June 9-12, 2022.

The company further informed that it plans to apply for marketing authorisation with the European Medicines Agency and with regulatory bodies in other countries where IV decitabine is approved for the treatment of AML.

“We are delighted with the outcome of the ASCERTAIN - AML trial, and the demonstration that the fixed-dose oral combination of decitabine and cedazuridine provides exposure equivalence to IV decitabine in the AML population,” Dr Harold Keer, the chief medical officer of Astex said.

“Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with AML who are not candidates to receive standard induction chemotherapy,” he added.

Pointing out that the trial was conducted during the Covid-19 pandemic, Dr Keer said, “This experience helped to highlight the potential advantage of an orally administered therapy.”  

“Parenterally administered hypomethylating agents have been a cornerstone of the treatment of AML patients who are not candidates to receive standard induction chemotherapy for over 10 years,” the lead author of the trial, Professor Klaus Geissler head of the Fifth Medical Department, Clinic Hietzing Hospital, Vienna, said.

“Oral ASTX727 may deliver a treatment alternative for patients with AML which potentially reduces the number of office visits and offers an option for patients to take their medication from the convenience and comfort of their homes,” he added.

The company further informed that based on the data from the trial, the oral decitabine and cedazuridine fixed-dose combination is also being investigated in combination with other agents in other blood-related cancers, with the first being investigating the all-oral combination of decitabine and cedazuridine with venetoclax for the treatment of AML.

It may be noted that the oral combination dose of oral decitabine and cedazuridine is approved in the U.S. and Canada for the treatment of intermediate and high-risk myelodysplastic syndromes (MDS), including chronic myelomonocytic leukaemia (CMML) and is the only approved oral hypomethylating agent that has demonstrated equivalent exposure to its IV form.