Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis

Claire N. Harrison, Vikas K. Gupta, Aaron T. Gerds, Raajit Rampal, Srdan Verstovsek, Moshe Talpaz, Jean Jacques Kiladjian, Ruben Mesa, Andrew T. Kuykendall, Alessandro M. Vannucchi, Francesca Palandri, Sebastian Grosicki, Timothy Devos, Eric Jourdan, Marielle J. Wondergem, Haifa Kathrin Al-Ali, Veronika Buxhofer-Ausch, Alberto Alvarez-Larrán, Andrea Patriarca, Marina KremyanskayaAdam J. Mead, Sanjay Akhani, Yuri Sheikine, Gozde Colak, John Mascarenhas

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

Abstract

Myelofibrosis (MF) is a clonal myeloproliferative neoplasm, typically associated with disease-related symptoms, splenomegaly, cytopenias and bone marrow fibrosis. Patients experience a significant symptom burden and a reduced life expectancy. Patients with MF receive ruxolitinib as the current standard of care, but the depth and durability of responses and the percentage of patients achieving clinical outcome measures are limited; thus, a significant unmet medical need exists. Pelabresib is an investigational small-molecule bromodomain and extraterminal domain inhibitor currently in clinical development for MF. The aim of this article is to describe the design of the ongoing, global, phase III, double-blind, placebo-controlled MANIFEST-2 study evaluating the efficacy and safety of pelabresib and ruxolitinib versus placebo and ruxolitinib in patients with JAKi treatment-naive MF. Clinical Trial Registration: NCT04603495 (ClinicalTrials.gov).

Original languageEnglish (US)
Pages (from-to)2987-2997
Number of pages11
JournalFuture Oncology
Volume18
Issue number27
DOIs
StatePublished - Sep 1 2022
Externally publishedYes

Keywords

  • CPI-0610
  • JAKi treatment-naive
  • MANIFEST-2
  • myelofibrosis
  • pelabresib
  • ruxolitinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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