Abstract
Imetelstat, a first-in-class telomerase inhibitor, demonstrated meaningful clinical benefit including a robust symptom response rate and potential overall survival benefit in IMbark, a phase II study in intermediate-2 or high-risk myelofibrosis (MF) patients who have relapsed after or are refractory to JAK inhibitors. We describe the rationale and design for the phase III trial, IMpactMF (NCT04576156), an open-label evaluation of imetelstat versus best available therapy, excluding JAK inhibitors, in MF patients refractory to JAK inhibitor. Imetelstat 9.4 mg/kg is administered as an intravenous infusion every 21 days. Primary objective is to assess overall survival. Secondary objectives include symptom and spleen responses, progression-free survival, clinical response assessment, bone marrow fibrosis reduction, safety and pharmacokinetics. Biomarker, cytogenetics and mutation analyses will be performed.
Original language | English |
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Pages (from-to) | 2393-2402 |
Number of pages | 10 |
Journal | Future Oncology |
Volume | 18 |
Issue number | 22 |
DOIs | |
State | Published - Jul 2022 |
Keywords
- JAK inhibitor
- biomarkers
- fedratinib
- imetelstat
- myelofibrosis
- pacritinib
- ruxolitinib
- safety
- survival
- telomerase