ASH 2024 | A propensity score matching analysis evaluating oral decitabine/cedazuridine in TP53-mutated MDS

In this abstract, it is in 180 patients who were enrolled in the decitabine-cedazuridine Phase III trial ASCERTAIN and also patients who were enrolled in the Phase II trial for the approval of the same drug. So we were interested to know what the outcomes, response rates and survival was of this patient with p53. As you all know, the p53-mutated patients have the worst outcomes of all patients with MDS and it’s usually measured in around a few months. Decitabine-cedazuridine was approved in 2020 for the treatment of patients with MDS. But over time we’ve learned that there are some differences between decitabine-cedazuridine and IV or parenteral decitabine, which was the control arm for this study. 

Now, we had a total of 50 patients with TP53 single-hit mutations. The way we divided these patients was between single-hit and multi-hit mutations based on their VAF cut-offs and the presence of del17 and minus 17 chromosomal abnormalities. 

So we found that compared to IV HMAs, IV decitabine or azacitidine, oral decitabine cedazuridine seems to have a longer survival compared to parenteral HMA. The way we did this comparison was using a propensity score matched analysis of patients in an institution, which was in this case MD Anderson. So we looked at 240 patients who had TP53 mutations who were treated with single agent HMA or single agent decitabine or azacitidine. And we found that the survival was longer for approximately five months in the oral decitabine treated patients within the Phase II and Phase III trials.

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