ASH 2024 | Results from the QuANTUM-First trial and comparisons with the RATIFY trial

The Phase III QuANTUM-First trial was an international randomized Phase III study for adults up to the age of 75 with FLT3 ITD mutated AML that were previously untreated. They were randomized between standard 7 and 3 chemotherapy with quizartinib or placebo for two weeks in sequence after the chemotherapy. If they achieved a CR or CRi, they could go on and receive quizartinib or placebo for two weeks after high-dose [inaudible] consolidation. Transplant was allowed at any time. And then at the end of consolidation or following allogeneic transplant, patients could then go on to receive up to 36 28-day cycles of quizartinib or placebo as maintenance, 144 weeks. The primary endpoint of the study was overall survival, and that was achieved showing a statistically significant benefit for the addition of quizartinib with a 22% reduction in the risk of death. Interesting sidelight about that is that in the RATIFY trial with midostaurin, it was the exact same 22% reduction in the risk of death, leaving us to compare the appropriate population from the RATIFY and the appropriate population from the QuANTUM-First. So these two separate studies. But if you look at patients that are less than the age of 60 and only with a FLT3-ITD mutation, I think the evidence suggests that quizartinib would be a better choice for those patients. I think what really drives my decision making about quizartinib for those patients is that the benefit of quizartinib was seen in patients who did and did not get an allo transplant in first remission. If you remember from the RATIFY trial, the only patients that seemed to have a benefit in terms of survival were those who received the midostaurin and then went on to a transplant. Not true with quizartinib. It was seen in both groups of patients.

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