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2025-03-04T12:40:21.000Z

SENTRY: A phase III study of selinexor in combination with ruxolitinib for JAKi-naïve MF

Mar 4, 2025
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Learning objective: After reading this article, learners will be able to cite a new clinical development in myelofibrosis.

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Selinexor is an investigational, oral XPO1 inhibitor being investigated for its ability to inhibit both JAK/STAT and non-JAK/STAT pathways, as well as its potential to synergize with ruxolitinib, the current standard-of-care therapy for MF.1

SENTRY (NCT04562389) is a global phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of selinexor in combination with ruxolitinib for the treatment of patients with JAKi-naïve MF.1 The rationale and study design of SENTRY has been published in Future Oncology by John Mascarenhas et al.1 Expected recruitment is approximately 350 patients.1


Key learnings
Participants will be randomized in a 2:1 ratio, with one group receiving selinexor (60 mg weekly) plus ruxolitinib and the other receiving placebo plus ruxolitinib, in 28-day cycles.

The primary endpoints are SVR35 and absolute mean change in TSS from baseline to Week 24.

Secondary objectives include safety, OS, PFS, and pharmacokinetics.
Exploratory endpoints focus on hemoglobin stabilization, reduction in gene mutation burden, and changes in bone marrow fibrosis.
The study aims to evaluate whether the combination of selinexor and ruxolitinib provides a more durable and effective treatment for MF compared to the current standard of care.

Abbreviations: JAKi, Janus kinase inhibitor; MF, myelofibrosis; OS, overall survival; PFS, progression-free survival; STAT, signal transducer and activator of transcription; SVR, spleen volume reduction; TSS, total symptom score; XPO1, exportin 1.

  1. Mascarenhas J, Maher K, Rampal R, et al. Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design. Future Oncol. 2025. Online ahead of print. DOI: 10.1080/14796694.2025.2461393

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