MOMENTUM study of momelotinib for myelofibrosis meets primary endpoint

On January 25, 2022, it was announced that the phase III, pivotal MOMENTUM (NCT04173494) study, evaluating momelotinib for the treatment of patients with symptomatic myelofibrosis (MF), achieved both its primary and major secondary endpoints; momelotinib has been associated with statistically significant improvements in symptoms, spleen size, and anemia.

Momelotinib

Momelotinib is an orally available inhibitor of Janus kinase 1 and 2 (JAK1/2) and activin A receptor type I/activin receptor-like kinase-2 (ALK-2). The agent is currently being evaluated across a number of clinical trials for the treatment of patients with MF who have received prior treatment with a U.S. Food and Drug administration (FDA)-approved JAK inhibitor.

MOMENTUM

MOMENTUM is a phase III, double-blind, randomized study investigating momelotinib versus danazol in patients aged ≥18 years with MF who meet the following eligibility criteria:

• Symptomatic with a Total Symptom Score (TSS) of ≥10.
• Anemic with hemoglobin of <10 g/dL at baseline.
• Prior treatment with a FDA-approved JAK inhibitor.

Across 21 countries, 195 patients were enrolled and randomized 2:1 to momelotinib (n = 130) and danazol (n = 65) treatment arms. Patients receiving danazol were able to transfer to momelotinib after 24 weeks of treatment, or earlier in the instance of splenic progression.

The study used the following endpoints to establish the value of momelotinib in MF:

• Primary endpoint: ≥50% reduction of TSS at the end of Week 24 compared to baseline.
• Secondary endpoints: transfusion independence for ≥12 weeks with maintained hemoglobin at ≥8 g/dL, and splenic response rate of ≥35% volume reduction at Week 24.

Results

Topline data from the MOMENTUM study demonstrate the encouraging efficacy and safety profiles of momelotinib versus danazol for patients with MF (Figure 1).

Figure 1. A Efficacy and B safety outcomes observed in patients enrolled in the MOMENTUM study*

AEs, adverse events; SRR, splenic response rate; TEAEs, treatment-emergent adverse events; TI, transfusion independence; TSS, Total Symptom Score.
*Data from BusinessWire¹

Findings from the MOMENTUM study suggest that momelotinib represents a promising treatment approach to MF with anemia, or patients with MF who may progress to symptomatic anemia.