ASH 2025 | The VICEROY study: VEN/AZA/GILT in newly diagnosed FLT3-mutated AML

The VICEROY study is a study that was designed as a multi-center study to, to a certain extent, confirm the findings that had come from single-center studies of triplet therapy in FLT3-mutated AML, newly diagnosed patients who were going to get a venetoclax azacitidine backbone, low-intensity therapy. So again, patients unfit for intensive chemotherapy plus a FLT3 inhibitor, who on studies done at MD Anderson looking at either gilteritinib or quizartinib, showed very high remission rates to a triplet combining ven-HMA and a FLT3 inhibitor. Those studies showed more than 90% CR rates, which is really quite impressive and very promising one- and two-year survivals. So we wanted to see whether we could do this in a multicenter trial. We also wanted to see whether we could refine the dosing of some of the agents, particularly the venetoclax, to see if lower doses might be safer and associated with the same benefit, but with less myelosuppression, which has really been a serious toxicity of this approach. 

So the study enrolled at, I want to say, at least eight different sites, including both community and academic centers. And impressively, the CR rates and the one-year survivals are almost identical to what was shown in the MD Anderson studies. I believe that the one-year survival is in excess of 70%, which is much better than what we’ve seen with historic controls or was published from the VIALE-A study in terms of the outcome in FLT3-mutated patients. And that this is holding up at the one-year and now coming up on two-year follow-ups really speaks to the power of this triplet approach, which I think is really going to change things. 

It’s notable that there are randomized studies comparing ven-aza to triplet approaches. The Myelomatch study, the EA02 study, is a study that Jessica Altman and I are both leading, which is using a similar approach, but is looking at a different endpoint for the study, which is MRD-CR. And so that study is randomizing patients between standard ven-aza and the triplet with gilteritinib. And we don’t have any early data on that. But I think this is going to certainly impact how we look at that study and where its role is. I still think the study’s goals are really quite important today. And I still do encourage people to enroll into Myelomatch. but I think now we’re getting more and more data on the triplet, particularly outside of just single institution studies, we have to weigh that into our planning going forward.

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