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ASH 2025 | Oral decitabine plus venetoclax for older unfit patients with AML: results of a Phase II study
Amer Zeidan, MBBS, MHS, Yale University and Yale Cancer Center, New Haven, CT, discusses the results of a Phase II trial (NCT04657081) combining oral decitabine-cedazuridine with venetoclax in older, unfit patients with newly diagnosed acute myeloid leukemia (AML). Dr Zeidan highlights that the safety and efficacy findings are encouraging, and notes that this all-oral regimen could be a significant milestone in the treatment of AML, offering a more convenient option for patients compared to current standards of care. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
As we know, the standard of care in older unfit patients with acute myeloid leukemia in the frontline setting is a hypomethylating agent plus venetoclax. So based on the VIALE-A, we have aza-ven as a standard of care. And we also have an oral version of a hypomethylating agent, oral decitabine, which is decitabine with cedazuridine, this has been shown to be pharmacokinetically equivalent to decitabine...
As we know, the standard of care in older unfit patients with acute myeloid leukemia in the frontline setting is a hypomethylating agent plus venetoclax. So based on the VIALE-A, we have aza-ven as a standard of care. And we also have an oral version of a hypomethylating agent, oral decitabine, which is decitabine with cedazuridine, this has been shown to be pharmacokinetically equivalent to decitabine. So this oral drug has been approved in Europe for AML, in the U.S. for high-risk MDS. And what we have done is that we combined oral decitabine with venetoclax. So this way you have total oral therapy, two oral pills to give to patients with newly diagnosed AML, which really was unheard of like, you know, 10 years ago to tell someone that you could treat acute myeloid leukemia with just two pills.
So the trial was a phase two trial in which we enrolled around 100 patients. And the data was very similar to VIALE-A. So the complete response rate, the complete response rate with incomplete count recovery was around 67%. The CR rate was around 47%. The CR was durable. The overall survival was around 15 months. All these numbers are similar to what we saw in VIALE-A. Importantly, the side effects profile also looks good. Early mortality was low.
So based on this, the combination is actually in front of the FDA right now, and we are expecting a decision by early 2026 in terms of approving this regimen to be used in older, unfit patients with acute myeloid leukemia. So I think if this does happen, it would be an important kind of milestone in the management of patients because being able to do oral drugs since the patients continue on this regimen as long as they are responding is something that I think would be a very welcome development by many patients who had to keep coming to get the injections of Azacitidine every month.
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