Researchers performed a new analysis of the IMerge trial on imetelstat for red blood cell (RBC) transfusion-dependent, lower-risk myelodysplastic syndromes (MDS) without chromosome 5q deletion. The analysis reaffirms the study’s initial findings that the telomerase inhibitor produces durable RBC transfusion independence (RBC-TI) and improves hemoglobin (Hb) levels. The results were presented at the European Hematology Association 2024 Hybrid Congress in Madrid, Spain.
In previously reported results from this global, phase III, double-blind, randomized study, imetelstat had higher rates of producing RBC-TI that lasted for eight weeks or longer, 24 weeks or longer, or one year or longer than placebo.
The new IMerge analysis found that among patients who achieved RBC-TI of eight weeks or longer, the median duration was 52 weeks for imetelstat recipients compared with 13 weeks for placebo recipients (P<.001). In patients who had RBC-TI of 24 weeks or longer, the median duration was 80 weeks for imetelstat recipients and 78 weeks for placebo recipients (P<.001). In patients with RBC-TI lasting one year or longer, the median duration was 132 weeks for imetelstat recipients and 131 weeks for placebo recipients (P<.001).
Of the imetelstat recipients who achieved RBC-TI lasting eight weeks or longer, 70% were still independent for 24 weeks or longer, and of these, 64% were still independent at one year or beyond.
The analysis also compared median increases from baseline in central Hb level between imetelstat and placebo recipients and found them to be higher in the former group. This outcome was seen among patients in the study who had achieved RBC-TI of eight weeks or longer (3.6 g/dL vs 0.8 g/dL), 24 weeks or longer (4.2 g/dL vs 1.1 g/dL), or one year or longer (5.2 g/dL vs 1.7 g/dL).
The investigators also assessed what percentage of patients in the imetelstat and placebo groups experienced both an Hb rise of 1.5 g/dL or greater and RBC-TI lasting for eight weeks or longer (28% vs 2%; P<.001), 24 weeks or longer (23% vs 0%; P<.001), or one year or longer (17% vs 0%; P<.001).
Reference
Santini V, Komrokji RS, Sekeres MA, et al. Overall survival, clinical benefit, and durable transfusion independence with imetelstat in the IMerge phase 3 trial of red blood cell-transfusion dependent lower-risk myelodysplastic syndromes. Abstract #S184. Presented at the European Hematology Association 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.