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ASH 2025 | Luspatercept initiated at the maximum-approved dose in transfusion-dependent LR-MDS: MAXILUS trial
In this video, Amer Zeidan, MBBS, MHS, Yale University and Yale Cancer Center, New Haven, CT, briefly comments on the findings of the ongoing Phase IIIb MAXILUS study (NCT06045689), which is being conducted to evaluate whether luspatercept treatment can be initiated at the maximum-approved dose in patients with transfusion-dependent (TD) lower-risk myelodysplastic syndromes (LR-MDS). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
MDS has been seeing a lot of, I think, important developments in the lower risk more than the higher risk disease. But in this ASH, I’ve actually been involved in a number, I think, of important presentations. The first one is called the MAXILUS trial, in which we are using luspatercept at the maximum dose. So luspatercept has been approved in lower-risk MDS in patients, both in the front line as well as the second-line anemia-dependent or transfusion-dependent anemia...
MDS has been seeing a lot of, I think, important developments in the lower risk more than the higher risk disease. But in this ASH, I’ve actually been involved in a number, I think, of important presentations. The first one is called the MAXILUS trial, in which we are using luspatercept at the maximum dose. So luspatercept has been approved in lower-risk MDS in patients, both in the front line as well as the second-line anemia-dependent or transfusion-dependent anemia. However, the drug is given in a titrational mode where you start with one milligram, you go to 1.33 and then 1.75. But what happens is many patients fall off during the process and they never escalate because doctors forget about the escalation. So in this phase 3 trial that is a non-randomized phase 3 piece trial, we are presenting starting at the highest dose from the beginning. And the data we show is actually demonstrating very good efficacy and very good safety. So I think that potentially could allow people to start with the highest dose from the get-go, which would be very important.
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