Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study

Abstract

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients’ quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor and major unmet need. Clinical trials of the Janus kinase (JAK)1/JAK2/activin A receptor type 1 inhibitor momelotinib have shown consistent anemia benefits, in addition to improvements in MF-related symptoms. The phase 3 MOMENTUM trial in symptomatic and anemic patients met its primary end point, with a greater proportion having a Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS) reduction ≥50% at week 24 with momelotinib versus danazol. To support the positive primary end point result, we conducted longitudinal, responder, and time-to-event analyses of patient-reported outcomes from MOMENTUM, as measured by the MFSAF, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Patient-Reported Outcomes Measurement Information System (PROMIS) assessments. These analyses demonstrated rapid and durable response benefits with momelotinib, with achievement of first TSS response by day 29 and continued improvement over time. Improvements favored momelotinib versus danazol for each MFSAF individual item, and greater improvements were observed for disease- and cancer-related fatigue and physical functioning at week 24, with significant results for multiple items/domains across the 3 assessments. These findings are consistent in demonstrating that momelotinib provides substantial symptom benefit.

Momelotinib – a promising advancement in the management of myelofibrosis in adults with anemia

“…Additionally, MMB was more effective in reducing both disease-related and cancer-related fatigue and enhancing physical functioning. These findings collectively suggest that MMB offers a rapid, progressive, and sustained benefit, enhancing the quality of life for patients with MF ( 38 ).…”

Is Treatment for Cytopenic Myelofibrosis Still an Unmet Clinical Need?

“…In the present HemaSphere issue, Mesa et al 12 present novel data from the MOMENTUM trial, bridging the knowledge gap of how MMB impacts MF-associated symptoms. In line with the results of SIMPLIFY-1 and -2, MMB improved anemia and led to a higher proportion of patients achieving TI compared to the danazol group.…”

ACVR1: A Novel Therapeutic Target to Treat Anemia in Myelofibrosis

“…Regarding TSS improvements at the same time point, 61% of the patients responded in the momelotinib arm since enrollment, and 59% of the patients in the danazol arm who crossed over to momelotinib were responders [ 86 ]. Further analysis of the TSS improvements in the MOMENTUM trial demonstrated ameliorated quality of life as well as rapidity and durability of benefits with momelotinib treatment [ 87 ]. Importantly, a recent post-hoc–time-dependent analysis of the data from the SIMPLIFY and MOMENTUM trials demonstrated the statistically significant associations of overall survival with TI arising from treatment with momelotinib [ 88 ].…”