Imetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design
John Mascarenhas, Claire N Harrison, Jean-Jacques 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 M Feller, Aleksandra Rizo, Srdan Verstovsek, John Mascarenhas, Claire N Harrison, Jean-Jacques 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 M Feller, Aleksandra Rizo, Srdan Verstovsek
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.
Keywords: JAK inhibitor; biomarkers; fedratinib; imetelstat; myelofibrosis; pacritinib; ruxolitinib; safety; survival; telomerase.
Source: PubMed