IMerge study demonstrates efficacy of imetelstat for patients with transfusion-dependent MDS
A study presented at the 2024 Society of Hematologic Oncology (SOHO) Annual Meeting confirmed the durability of red blood cell (RBC) transfusion-independence in patients with myelodysplastic syndromes (MDS) who were treated with imetelstat.
The double-blind, phase 3 trial included patients with low-risk MDS who were RBC-dependent and relapsed, were refractory to, or were ineligible for erythropoiesis-stimulating agents. Patients were randomized 2:1 to receive imetelstat 7.5 mg/kg or placebo until disease progression, unacceptable toxicity, or withdrawal.
Among patients treated with imetelstat, median RBC transfusion-independence was 52 weeks (n=47/118) versus 13 weeks (n=9/60) for placebo (P<.001).
Among those who were treated with imetelstat for 8 or more weeks:
- 70% remained RBC transfusion-independent for 24 or more weeks
- 64% remained transfusion-independent for a year or more
As of January 2024, median overall survival (OS) was 40.4 months with imetelstat and not estimable with placebo.
Among those treated with imetelstat, the 2-year OS rate was:
- 78% overall
- 81% in those who were transfusion-independent for 8 or more weeks
“Updated analyses confirm RBC transfusion-independence achievement with imetelstat is durable and associated with improved hemoglobin level. Preliminary OS analysis suggests no detriment with imetelstat versus placebo,” the researchers concluded.
Imetelstat was recently approved by the US Food and Drug Administration.
Reference
Santini V, Komrokji RS, Sekeres, MA, et al. Overall survival (OS), clinical benefit, and durable red blood cell (RBC) transfusion independence (TI) with imetelstat in the IMerge phase 3 trial of RBC-transfusion dependent (TD) lower-risk myelodysplastic syndromes (LR-MDS). Abstract MDS-157. Presented at the 2024 SOHO Annual Meeting, September 4-7, 2024; Houston, TX.
