The IMerge trial was a trial that was comparing imetelstat, that is a specific telomerase inhibitor, to supportive care, to placebo, in patients with lower-risk MDS measured with the old IPSS. These patients had to be transfusion dependent with a high burden of transfusion dependence, higher than four units in the eight weeks.
So this trial showed that at six months the percentage of patients who achieved transfusion independence for red blood cells longer than eight weeks was 40% compared to 15% of the placebo...
The IMerge trial was a trial that was comparing imetelstat, that is a specific telomerase inhibitor, to supportive care, to placebo, in patients with lower-risk MDS measured with the old IPSS. These patients had to be transfusion dependent with a high burden of transfusion dependence, higher than four units in the eight weeks.
So this trial showed that at six months the percentage of patients who achieved transfusion independence for red blood cells longer than eight weeks was 40% compared to 15% of the placebo. So indeed significantly more patients achieved transfusion independence. These patients had a durable transfusion independence because overall, 18% of the complete cohort of patients achieved the transfusion independence, continuous transfusion independence, longer than one year. So indeed a relevant result.
In this trial were included all patients with as I mentioned with lower-risk MDS with or without ring sideroblast and they were patients who were not pre-treated with lenalidomide or hypomethylating agents, but they had the possibility to be treated before with ESA, failed and become transfusion dependent or non-eligible to ESAs.
So the proportion of patients who were RS negative in this trial was not very high, was not the majority, was around 30%, percent, but what was clear was that these patients had a very good response rate to treatment with imetelstat achieving transfusion independence, meaning that even if the majority of patients were RS positive, as always happens in these lower-risk trials with transfusion dependent patients, the activity of the drug was clear also in RS negative. And that’s why we collected the data from previous Phase II and other studies that could confirm this observation. And indeed it is a constant and consistent finding.
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