Trial reportInternational journal of hematology2025
Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia.
Trial report in International journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04173494 (A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib), which is not on this map. Not yet cited in PubMed.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy
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Authors and funding
14 authors.
Funding
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Abstract
introductionThis post hoc analysis investigated the efficacy and safety of momelotinib in the Asian subpopulation of MOMENTUM (NCT04173494).
methodsPatients were randomized 2:1 to momelotinib 200 mg once daily (QD) plus danazol placebo (momelotinib group) or danazol 600 mg QD plus momelotinib placebo (danazol group) for 24 weeks (W), after which they could receive open-label momelotinib or danazol. PRIMARY ENDPOINT: W24 total symptom score (TSS) response rate (≥ 50% reduction from baseline). W24 key secondary endpoints: transfusion independence rate; mean TSS change from baseline; splenic response rate; rate of zero transfusions.
resultsSeventeen Asian patients with myelofibrosis were included (momelotinib: n = 11; danazol: n = 6). TSS response rate at W24 was 36.4% with momelotinib and 0% with danazol. Secondary endpoints favored momelotinib and were consistent with the intention-to-treat population. Grade ≥ 3 treatment-emergent adverse events were reported in 36.4 and 66.7% of the momelotinib and danazol groups, respectively, including one grade ≥ 3 anemia in the momelotinib group. Treatment interruption and/or dose reduction occurred in 18.2 and 16.7% of the momelotinib and danazol groups, respectively. Two danazol-treated patients discontinued study treatment.
conclusionIn the Asian subpopulation of MOMENTUM, momelotinib improved myelofibrosis-associated symptoms, anemia measures, and spleen response, with generally favorable safety versus danazol.
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