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.

  • TLDR: MMB good for thrombocytopenia 20k is ok, and is good for anemia

  • Design: Phase 3 randomized multi-center trial

  • Number of patients: 195 patients received MMB and 65 patients received DAN

  • 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

  • Agent: MMB (200 mg QD) vs DAN (600 mg QD)

  • Treatment line: Previously treated with a JAK inhibitor

  • Trial Acronym or NCTId Number: NCT04173494

  • Compare efficacy:

ParameterResult
TSS response rate at 24 weeksMMB: 72% DAN: 58%
RBC transfusion independence rateMMB: 13% DAN: 15%
Splenic response rateMMB: 22% DAN: 12%
HR for OS at 24 weeksHR=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.