NOTE
🌱 created from: treatment-of-myelofibrosis
momentum
MOMENTUM: Phase 3 randomized study of momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic myelofibrosis (MF) patients previously treated with a JAK inhibitor.
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TLDR: MMB good for thrombocytopenia 20k is ok, and is good for anemia
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Design: Phase 3 randomized multi-center trial
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Number of patients: 195 patients received MMB and 65 patients received DAN
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Patients characteristics: Primary or post-ET/PV MF; DIPSS high risk, Int-2, or Int-1; MF Symptom Assessment Form Total Symptom Score (MFSAF TSS) ≥10; Hgb <10 g/dL; prior JAKi for ≥90 days, or ≥28 days if RBC transfusions ≥4 units in 8 wks or Gr 3/4 thrombocytopenia, anemia, or hematoma; palpable spleen ≥5 cm
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Agent: MMB (200 mg QD) vs DAN (600 mg QD)
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Treatment line: Previously treated with a JAK inhibitor
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Trial Acronym or NCTId Number: NCT04173494
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Compare efficacy:
Parameter | Result |
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TSS response rate at 24 weeks | MMB: 72% DAN: 58% |
RBC transfusion independence rate | MMB: 13% DAN: 15% |
Splenic response rate | MMB: 22% DAN: 12% |
HR for OS at 24 weeks | HR=0.506, p=0.0719 |
- Highlight of toxicity: Most common Grade ≥3 adverse events were thrombocytopenia and anemia, with similar rates between MMB and DAN. Peripheral neuropathy occurred in a small percentage of patients with MMB.
- One line summary: MMB showed superior efficacy in symptom responses, transfusion requirements, and spleen responses compared to DAN with comparable safety, offering a potential treatment option for MF patients with anemia.