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ASH 2025 | Long-term outcomes from the Phase III IMerge trial of imetelstat in LR-MDS
In this interview, Valeria Santini, MD, University of Florence, Florence, Italy, discusses the long-term outcomes from the randomized, double-blind, placebo-controlled, Phase III IMerge trial (NCT02598661) investigating imetelstat for lower-risk myelodysplastic syndromes (LR-MDS), highlighting that the data are encouraging. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The IMerge trial is a study that is evaluating transfusion independence achievement in patients with IPSS intermediate or low risk who have a high burden of transfusion dependence, so more than four red blood cell units in eight weeks, and is comparing imetelstat, a telomerase inhibitor, to a placebo. So the trial was successful. 40% of patients treated with imetelstat achieved transfusion independence longer than eight weeks versus 15% in the placebo arm...
The IMerge trial is a study that is evaluating transfusion independence achievement in patients with IPSS intermediate or low risk who have a high burden of transfusion dependence, so more than four red blood cell units in eight weeks, and is comparing imetelstat, a telomerase inhibitor, to a placebo. So the trial was successful. 40% of patients treated with imetelstat achieved transfusion independence longer than eight weeks versus 15% in the placebo arm.
So the drug is very interesting because it may indeed induce a long duration of response; the majority of patients achieving the primary objective of transfusion independence for eight weeks will have six months of transfusion independence. And finally, of all the patients, the intention-to-treat patients, 18% will have transfusion independence longer than one year. So we focused on this subgroup of patients because we wanted to understand whether this long transfusion independence was mirrored by a longer survival.
So in the intention-to-treat, all the patients versus placebo did not show a significant prolongation of survival, but when we look at the more than one year transfusion-independent patients, you indeed have a signal, especially after 42 months of survival, so the study was not powered to evaluate overall survival, but there is a trend to obtain a better overall survival in treated patients. Now, this is just the beginning. We have to understand exactly the characteristics of patients, whether they had other treatment after imetelstat, but it’s encouraging data. Also, because this drug is endowed with a disease-modifying effect, meaning that the variant allele frequency of the somatic mutation present in the patients is decreasing significantly, and this correlates with the response.
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