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ASH 2020 | Risk stratified analysis of CPX-351 versus 7 + 3 in older adults with AML

Thomas Prebet, MD, PhD, Yale School of Medicine, New Haven, CT discusses the findings of a retrospective analysis of the results of a Phase III study (NCT01696084) of outcomes in older acute myeloid leukemia (AML) patients treated with CPX-351, stratified by risk subgroup. CPX-352 is a dual-drug made up of daunorubicin and cytarabine and was compared to the conventional 7 + 3 chemotherapy regimen. The analysis showed that complete remission (CR) rates were higher in the CPX-351 arm for both intermediate- and high-risk AML. Improvements were also seen in early mortality rate, median overall survival, and post-hematopoietic cell transplant outcomes for both risk groups. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

Transcript (edited for clarity)

We have the CPX-351 that’s been approved based on a Phase III study in primary and secondary acute myeloid leukemia presenting from a high-risk features. One of the things that basically has became more standard routine since the initiation of the trial is basically the stratification of the risk of patient based on cytogenetics, but also molecular data.

The main risk stratification tool that we are using is the ELN, European Leukemia Net, 2017 stratification and some mutation like [inaudible] TP53 or ASXL1are considered as high-risk...

We have the CPX-351 that’s been approved based on a Phase III study in primary and secondary acute myeloid leukemia presenting from a high-risk features. One of the things that basically has became more standard routine since the initiation of the trial is basically the stratification of the risk of patient based on cytogenetics, but also molecular data.

The main risk stratification tool that we are using is the ELN, European Leukemia Net, 2017 stratification and some mutation like [inaudible] TP53 or ASXL1are considered as high-risk. And that’s something that is pretty new as compared to the holder classification tool that we use.

And so the question that we had as we had a good proportion of the patient that were included in this phase III, for which we had the extensive sequencing, was to know if basically stratifying this patient in the subgroup of risk, based on the year end 2017 will give us some additional information on which patients are really benefiting from the treatment. And either at any group of patients that do not have a benefit.

And so we saw that, especially in the newly defined intermediate risk and adverse risk setting, we see some benefit of the CP-351 in comparison to the conventional 7+3 chemotherapy. And the one thing that was also interesting is that we found that for patient that have an adverse risk disease and a TP53 mutation, which is roughly a good third of these high-risk patient, we do not see a significant benefit of CP-351 in comparison to 7+3.

Basically, the chances of response and the chances of overall survival are similar between the two arms re-stratified using the ELN 2017 and basically compared for the presence or absence of the TP53 mutation. That also mean that we saw a more striking benefit of the CP-351 for patient with an adverse-risk disease without the TP53 mutation. And we see this from an overall survival standpoint, but also when it comes to post-transplant outcome. Which is extremely important, as we know that the risk of relapse in general for this challenging disease is really high.

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Disclosures

Thomas Prebet, MD, PhD, has done consultancy work for BMS and AbbVie, and has received research support from BMS and Jazz.

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