By Pankit Vachhani, MD
Edward Pearson, MD
Edward Pearson, MD
Summary of Momelotinib Clinical Trials and Second-Line Applications
SIMPLIFY-1 (First-Line Setting)
- Efficacy comparison with ruxolitinib in newly diagnosed myelofibrosis:
- Spleen response: Momelotinib demonstrated spleen volume reduction
- Symptom improvement: Not as robust as ruxolitinib
- Anemia benefit: Preserved transfusion independence at week 24 vs baseline, while ruxolitinib showed slight decline
- Clinical considerations for newly diagnosed myelofibrosis with moderate anemia:
- Potential benefit of single-agent therapy (avoiding combination with erythropoiesis-stimulating agents)
- When anemia contributes significantly to symptom burden, momelotinib may be preferable
SIMPLIFY-2 (Second-Line Setting)
- Study design: Effectively a comparison of momelotinib vs ruxolitinib in previously treated patients
- No washout period between treatments
- Key outcomes:
- Spleen response: Comparable between momelotinib and control (“a wash”)
- Anemia: Clear advantage for momelotinib
- Symptom control: Superior with momelotinib in the second-line setting
- Expert opinion on optimal positioning:
- Panel indicated greater preference for momelotinib in the second-line setting
- Particularly valuable in patients with worsening anemia or diminishing spleen response on ruxolitinib
- Setting appropriate expectations is crucial; emphasize anemia and symptom benefits rather than additional spleen reduction