More than 820 patients with myelofibrosis have been treated with momelotinib, with treatment duration ranging beyond 9 years.
A substantial body of clinical data provides evidence of momelotinib’s clinical activity in intermediate and high-risk myelofibrosis, drawn principally from two randomized Phase 3 pivotal studies:
- SIMPLIFY-1: a double-blind, randomized, head-to-head comparison of momelotinib vs ruxolitinib in JAK inhibitor treatment naïve myelofibrosis patients (N=432)
- SIMPLIFY-2: a randomized study versus best available therapy in patients previously treated with ruxolitinib (N=156). Approximately 90% of patients received ruxolitinib as best available therapy in this study.
Data from these trials demonstrated that momelotinib could provide a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, robust constitutional symptom improvements and comparable spleen control to ruxolitinib.
In contrast to other JAK inhibitors, momelotinib also demonstrated very low rates of thrombocytopenia and other hematological toxicities, which consequently enabled maximal dose intensity to be sustained during chronic therapy, further supporting the compound’s unique potential for benefit in myelofibrosis.