EHA 2025 | Final results of the VEN-A-QUI trial: VEN-AZA or VEN-LDAC combined with quizartinib in non-fit AML

This is a trial that has been performed by all the group of PETHEMA and we included patients from 10 clinical hospitals here in Spain. We focus on patients with acute myeloid leukemia in older patients and not fit patients to receive intensive chemotherapy. The aim of the trial was to find a dose of quizartinib associated with azacitidine and venetoclax or cytarabine and to see the effectiveness of the combination of the triplet. 

We found in the first phase of the trial that quizartinib with 40 milligrams was tolerable for the patients with low-dose cytarabine and venetoclax. And we find a dose of 60 milligrams of quizartinib associated to venetoclax and cytarabine. And the Phase II of the trial, what there was seen was the effectiveness of the trial, showed that both arms, low-dose cytarabine and azacitidine, were similar in results. 

We see something that we think that is very important in subsequent trials. First of all, we see that the effectiveness of the trial was mainly in patients with no previous myelodysplastic syndrome or not treated previously with azacitidine. This trial in the Phase III was similar to the trial of low-dose cytarabine, azacitidine, and venetoclax. And we include all type of patients with previously minor dysplastic or previous treatment with azacitidine. And we see that the complete response rate was more than 50% of the patients. We see that in the patients with no previous myelodysplastic syndrome or with FLT3 ITD mutation the rates of complete remission and the overall survival was very interesting and very amazing. We can say that there are 19 patients, some of them have achieved the incredible age of 90 years old. They are in complete remission with minimal residual disease negativity. And it’s curious because even in the trial with azacitidine and venetoclax, there weren’t differences between patients with previously myelodysplastic or de novo acute myeloid leukemia. 

There are some caveats in the trial. First of all, the number of patients. We expect that we are going to perform a Phase III trial in this type of patients with no previously myelodysplastic syndrome. And the second, we don’t have a clear comparison with azacitidine and venetoclax in order to see if this is a very new or more potent combination with the triplet. 

I can say that seeing the results of the VEN-A-QUI trial, perhaps the combination of an inhibitor of FLT3 can be successful in patients with a phenotype of de novo acute myeloid leukemia. Perhaps in myelodysplastic syndromes, this type of triplet chemotherapy doesn’t work.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.