Srdan Verstovsek, MD, PhD, Medical Oncologist and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discusses the top-line results from the phase 3 MOMENTUM trial of momelotinib in myelofibrosis patients.

Myelofibrosis is a rare cancer characterized by extensive scarring of the bone marrow and the disruption of normal blood cells production. This leads to severe anemia that can cause weakness and fatigue. Bone marrow scarring can also lead to low platelet levels, which increases the risk of bleeding. Additionally, myelofibrosis often causes an enlarged spleen.

As Dr. Verstovsek explains, the MOMENTUM trial is a phase 3, randomized, double-blind clinical trial evaluating momelotinib in myelofibrosis patients who are symptomatic and anemic and previously treated with an approved JAK inhibitor. The top-line results from this trial were recently announced

The study was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and splenomegaly (enlarged spleen). In this study, danazol was selected as the treatment comparator given its use to ameliorate anemia in patients with myelofibrosis. Patients were randomized 2:1 to receive either momelotinib (n = 130) or danazol (n = 65). After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib, and early cross-over to momelotinib was available for confirmed symptomatic splenic progression.

The primary endpoint of the study is Total Symptom Score (TSS) reduction of >50% over the 28 days immediately prior to the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form (MFSAF). Secondary endpoints included Transfusion Independence (TI) rate for >12 weeks immediately prior to the end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate (SRR) based on splenic volume reduction of >35% at Week 24.

The topline results demonstrated a TTS reduction  >50% in 25% of patients in the momelotinib group and 9% in the danazol group (P = .0095). Momelotinib was also demonstrated to control and improve anemia in patients which led to 31% of patients in the momelotinib cohort becoming transfusion independent compared to 20% in the control arm. Additionally, the SPR was 23% and 3%, in the momelotinib and control arm, respectively.

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