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ISAL 2025 | Findings from a Phase III trial of azacitidine and venetoclax plus pevonedistat in AML

Cristina Papayannidis, MD, PhD, University of Bologna, Bologna, Italy, comments on the results of a Phase III trial combining azacitidine and venetoclax with pevonedistat in patients with newly diagnosed acute myeloid leukemia (AML). The combination was well-tolerated, but it did not demonstrate superiority in overall survival. However, the trial did show significant activity in a subset of patients with IDH mutations, a crucial finding given the lack of available IDH inhibitors in many countries. This interview took place at the 19th International Symposium on Acute Leukemias (ISAL XIX) in Munich, Germany.

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Transcript

This trial has been recently published. It was a Phase III trial combining AZA-VEN plus placebo versus AZA-VEN and pevonedistat. This combination was very well tolerated even if unfortunately a superiority in terms of overall survival was not demonstrated. But looking at the results more into the details, what we found was a great activity of this triple combination in a subset of patients, those with IDH mutations...

This trial has been recently published. It was a Phase III trial combining AZA-VEN plus placebo versus AZA-VEN and pevonedistat. This combination was very well tolerated even if unfortunately a superiority in terms of overall survival was not demonstrated. But looking at the results more into the details, what we found was a great activity of this triple combination in a subset of patients, those with IDH mutations. And this is a very important point because we know that for these patients at the moment, at least in my country, we don’t have IDH inhibitors available. We are still waiting for them and so it was a very important finding.

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