Open AccessImetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design
Author(s) -
John Mascarenhas,
Claire Harrison,
JeanJacques Kiladjian,
Rami S. Komrokji,
Steffen Koschmieder,
Alessandro M. Vannucchi,
Tymara Berry,
Denise Redding,
Laurie Sherman,
Souria Dougherty,
Lixian Peng,
Libo Sun,
Fei Huang,
Ying Wan,
Faye Feller,
Aleksandra Rizo,
Srđan Verstovšek
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2022-0235
Subject(s) - medicine , myelofibrosis , clinical trial , oncology , refractory (planetary science) , phases of clinical research , ruxolitinib , surgery , gastroenterology , bone marrow , physics , astrobiology
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.