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ASH 2024 | Preliminary results of LusPlus: initiating luspatercept at the maximum approved dose in MDS
Uwe Platzbecker, MD, University of Leipzig, Leipzig, Germany, briefly comments on the rationale and preliminary results of the LusPlus trial (NCT05181592), a study investigating the safety and efficacy of forgoing luspatercept dose-escalation in patients with transfusion-dependent anemia due to very low, low, and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts. The study initiates treatment with the maximum approved dose, and early results suggest that this dosing strategy does not yield any new safety signals and may lead to improved response rates. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
The current label of luspatercept recommends to increase the dose, to dose escalate, from one mg per kg up to 1.75 mg per kg. So that’s how the pivotal trials design actually was made at those days. Of course, the rationale came up, why escalating during the first six months? Why not starting with the highest dose? Because also the 1.75 mg per kg has been shown to be safe and, of course, efficacious...
The current label of luspatercept recommends to increase the dose, to dose escalate, from one mg per kg up to 1.75 mg per kg. So that’s how the pivotal trials design actually was made at those days. Of course, the rationale came up, why escalating during the first six months? Why not starting with the highest dose? Because also the 1.75 mg per kg has been shown to be safe and, of course, efficacious. This was the rationale of this German trial by the German MDS study group. And the data are still preliminary. Every patient anticipated is included into the trial already. But I think what we can say at the very beginning is that no new safety signals emerged, and a couple of patients with a very fast response, including transfusion independence. So the study is still running. But I think what we can say so far is that the data are encouraging.
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Disclosures
Amgen: Consultancy, Research Funding; BMS: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Other: Travel support, Research Funding; MDS Foundation: Membership on an entity’s Board of Directors or advisory committees; Abbvie: Consultancy, Research Funding; Curis: Consultancy, Honoraria, Research Funding; Geron: Consultancy; Janssen: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Novartis: Consultancy, Research Funding.
