For over 10 years, hypomethylating agents given via an IV have been a primary treatment of AML patients who do not qualify for standard 7+3 induction chemotherapy. Hypomethylating agents are types of chemo drugs that affect the way some genes inside of a cell are controlled. These drugs activate certain genes that help cells mature. They also kill cells that are dividing rapidly. These drugs can stimulate anti-tumor immunity in AML.
Recently, Astex Pharmaceuticals announced the results of the phase 3 ASCERTAIN study that evaluated oral decitabine and cedazuridine fixed-dose combination (ASTX727 or DEC-C) tablets versus IV decitabine in adults with AML.
- ASTX727 was orally administered over a 5 day period
- The pill contained decitabine (35mg) and cedazuridine (100mg)
- It was given once daily for a 28 day cycle
- The pill was compared with IV decitabine (20mg) administered daily in 1 hour infusions for 5 days on a 28 day cycle.
- To learn more about the trial, click here
“By inhibiting cytidine deaminase in the gut and the liver, ASTX727 is designed to allow for oral delivery of decitabine over 5 days in a given cycle to achieve comparable systemic exposure to IV decitabine administered over 5 days.” ASTX727 is an investigational compound and is not currently approved in any country other than the U.S., Canada and Australia.
This new drug can provide a treatment option for adult patients that can potentially reduce the number of doctor office visits since it can be taken orally. Patients can conveniently take the medication from the comfort of their own home. Based on the success of combining decitabine and cedazuridine, other all-oral combinations are being studied, such as decitabine and cedazuridine with venetoclax.
“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.” This study was conducted during the COVID-19 pandemic. Which helped to highlight the importance of orally administered drugs that can be taken at home.
“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.” said Harold Keer, MD, PhD, chief medical officer of Astex Pharmaceuticals, Inc. Data from the study will be presented on June 10, 2022, as part of the annual meeting of the European Hematology Association (EHA) in Vienna, Austria.
To learn more about ASTX727, listen to a podcast episode we recorded with AML expert, Dr. Gabriel Mannis in September of 2021. Dr. Mannis explains all about this new drug and what it's use means for AML patients.
about the author
Lisa Foster is a mom of 3 daughters, a puzzle lover, writer and HealthTree advocate. She believes in the mission of the foundation and the team that builds it forward. She calls Houston, Texas home.