Among patients with symptomatic, anemic myelofibrosis, momelotinib may some improve outcomes compared with danazol, according to research presented at the 2022 ASCO Annual Meeting.
Momelotinib is an orally administered JAK1/2 and ACVR1/ALK2 inhibitor. Previous research has suggested that momelotinib may improve clinical symptoms of myelofibrosis as well as reduce reliance on red blood cell (RBC) transmission and improve spleen volume metrics.
For the phase 3 MOMENTUM trial (ClinicalTrials.gov Identifier: NCT04173494), researchers evaluated the comparative safety and efficacy of momelotinib and danazol among patients with symptomatic and anemic myelofibrosis. All patients had previously received a JAK inhibitor, and were evaluated for symptoms, anemia, and splenic response rate at 24 weeks. The primary endpoint was Total Symptom Score (TSS) response per myelofibrosis Symptom Assessment Form TSS criteria.
Overall, of 195 patients enrolled, 94 and 38 patients were randomly assigned 2:1 to receive momelotinib and danazol, respectively, completed the full 24-week treatment phase. At baseline, in the experimental and danazol groups, the median TSSs were 28 and 26, respectively; median hemoglobin levels were 8.1 and 7.9 g/dL, and median platelets were 97 and 94 x 109/L.
Analysis showed that TSS responses were improved in the momelotinib group (24.6%) compared with the danazol group (9.2%; P =.0095); the zero transfusion rate (35.4% vs 16.9%, respectively; P =.0012) and the splenic response rate of at least 35% (23.1% vs 3.1%; P =.0006) were also superior in the momelotinib group. No improvement in 24-week overall survival was, however, noted.
Treatment-related adverse events led to discontinuation in 18% of patients in the momelotinib group vs 23% of patients in the danazol group.
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures.
Mesa RA, Gerds AT, Vannucchi A, et al. MOMENTUM: phase 3 randomized study of momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic myelofibrosis (MF) patients previously treated with a JAK inhibitor. Presented at: ASCO 2022; June 3-7, 2022. Abstract 7002.