MOMENTUM Trial Outcomes: Guiding Therapy for Myelofibrosis With Anemia and Splenomegaly

elists discuss how the MOMENTUM trial demonstrated momelotinib’s superiority over danazol in symptomatic anemic myelofibrosis patients, showing significant improvements in symptoms (the primary end point), meaningful spleen volume reduction (SVR25/SVR35), and anemia benefits, with experts noting that the inclusion of a washout period provided clearer evidence of momelotinib’s efficacy profile compared to the SIMPLIFY-2 trial.

Summary of MOMENTUM Trial: Momelotinib in Anemic, Symptomatic Myelofibrosis

Study Design and Population

• Patient characteristics:
  • Required hemoglobin <10 g/dL
  • Symptomatic disease
  • Previously treated with Janus kinase (JAK) inhibitor therapy
• Design elements:
  • Primary end point was symptom-driven
  • Active comparator arm (danazol) rather than placebo
  • Included a washout period (unlike SIMPLIFY-2)

Key Findings

• Primary end point:
  • Momelotinib demonstrated superior symptom benefits compared to danazol
• Secondary end points:
  • Multiple secondary end points met with superiority
  • Stronger spleen volume reduction data (SVR25, SVR35) than in SIMPLIFY-2
  • Confirmed anemia benefits

Clinical Implications

• Comprehensive benefit profile:
  • Triple benefit: spleen reduction, symptom improvement, and anemia benefits
  • Washout period may have contributed to clearer demonstration of spleen benefits compared to SIMPLIFY-2
• Clinician perspective:
  • Some practitioners noted less direct relevance of danazol comparison in their practice
  • Nevertheless, provided further evidence of momelotinib’s anemia benefit
  • Results support momelotinib use in patients with anemic, symptomatic myelofibrosis who have received prior JAK inhibitor therapy

The MOMENTUM trial reinforces momelotinib’s position in the treatment algorithm, particularly for patients with anemia who have been previously treated with other JAK inhibitors.

Read more