MEDALIST Trial Updates: ASH 2022 and EHA 2022

EP: 1.MDS: Typical Patient Presentation, Diagnostic Process, and Evolving Terminology

EP: 2.Tools for Risk Stratification and Prognosis in MDS

EP: 3.Considerations for MDS Pathology and Risk Status Reporting

EP: 4.First-Line Treatment Options for Lower-Risk MDS

EP: 5.Second-Line Treatment Options for Lower-Risk MDS

EP: 6.Case 1 Presentation: Lower-Risk MDS with Multiple Chromosomal Abnormalities

EP: 7.Case 1: Expert Panelist Commentary

EP: 8.The Impact of p53 Mutations and 5q Deletions on Lower-Risk MDS Treatment Response

EP: 9.Case 2 Presentation: Lower-Risk MDS-RS With an SF3B1 Mutation

EP: 10.Case 2 Discussion and Considerations for Second-Line Treatment Selection

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EP: 11.MEDALIST Trial Updates: ASH 2022 and EHA 2022

EP: 12.Additional Updates in Second-Line Treatment of Lower-Risk MDS

EP: 13.Higher-Risk MDS: First- and Second-Line Therapies and Case 3 Presentation/Discussion

EP: 14.Recent Data Updates in Higher-Risk MDS

EP: 15.MDS/MPN-RS-T Overlap Syndromes

EP: 16.Summary of Unmet Needs and Future Directions in MDS

Transcript:

Rami Komrokji, MD: At ASH [American Society of Hematology Annual Meeting], we had a lot of presentations from the MEDALIST study. Uwe, give us more details on updates on luspatercept that were presented at EHA [European Hematology Association Congress] and ASH. You’ve been involved in all this, so we’ll discuss those in a little more detail.

Uwe Platzbecker, MD: Thank you, Rami. There have been a lot of updates on the initial MEDALIST trial with the longer follow-up data. The results confirm the efficacy and superiority of luspatercept compared with placebo. Also, the durability of response was shown. The observation was made that for patients who have a durable response and get another transfusion event, if you continue treatment beyond this transfusion event, they may get a second, a third, even a fourth consecutive period of transfusion independence. This is very important information for hematologists and clinicians treating patients in the clinical routine.

No. 2, long-term safety with regard to AML [acute myeloid leukemia] evolution has been reported and studied. There’s no imbalance between the arms of luspatercept vs placebo, which is reassuring. This agent can be applied safely and for a long time, and the survival data have been presented. If you compare survival between the 2 arms, blank luspatercept vs placebo, there’s no significant difference confirming it’s safety. But it’s important—and something we always hope for—that for most cases, patients responding have a better survival than nonresponders.

You may say that in hematology-oncology, the responders do better than nonresponders. My counter statement is that if safety is assured, then this is the case. Luspatercept is a safe agent with no significant adverse effects in the majority of the cases. That’s a very important take-home message: patients responding benefit with regard to improvement of hemoglobin levels and transfusion independence, but they also have a better survival compared with patients not responding.

Rami Komrokji, MD: The other thing we saw at ASH is that there are some real-world data coming out. We reported our experience. Our colleagues from Italy had a nice presentation on real-world data. Our experience is duplicating or showing similar benefit that was seen in the MEDALIST study, in terms of response rates, durability, and safety of the drug. As we discussed, hopefully the role of luspatercept will be expanded beyond the current use of the drug.

Transcript edited for clarity.