Trial in Progress: A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Adult Patients With Myelofibrosis (MANIFEST-3) (SOHO 2026) - Sep 1, 2026 - Abstract #MPN-555; Location: LEVEL 3, HALL B3; P3 | "MANIFEST-3 will build on the positive findings of MANIFEST-2 (NCT04603495) by evaluating efficacy and safety of PELA+RUX vs PBO+RUX in the broad population, including patients with higher symptom burden. This population may benefit more from PELA+RUX than RUX alone, aiming to address disease biology and achieve deeper, more durable spleen responses. AE: adverse event, ePROs: electronic patient-reported outcomes, MFSAF: Myelofibrosis Symptom Assessment Form, NF-κB: nuclear factor kappa-light-chain-enhancer of activated B cells, OS: overall survival, PFS: progression-free survival, QoL: quality of life."
Clinical • P3 data • Essential Thrombocythemia • Hematological Malignancies • Leukemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera
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John Mascarenhas MD 1; Prithviraj Bose MD 2; Martin Griesshammer 3; Rami Komrokji MD 4; Andrew Kuykendall MD 4; Ruben Mesa MD 5; Francesca Palandri MD 6; Francesco Passamonti MD 7; Raajit Rampal MD PhD 8; Pankit Vachhani 9; Zhijian Xiao 10; Grace Cleary 11; Harald Maier BSCH 12; Sadhvi Khanna MBAMPH 13; Claire Harrison MD 14
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