Momelotinib proved superior to danazol for key outcomes in a phase 3 trial of patients with symptomatic and anemic myelofibrosis.
Momelotinib improved symptoms and spleen size, and there was a trend toward an improvement in overall survival.
These results, from the MOMENTUM trial, were presented at the EHA 2022 Hybrid Congress by Srdan Verstovsek, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston.
MOMENTUM (ClinicalTrials.gov Identifier: NCT04173494) enrolled and randomized 195 patients with symptomatic and anemic myelofibrosis who had previously received treatment with a JAK inhibitor.
Patients were randomly assigned to receive momelotinib at 200 mg daily (n=130) or danazol at 600 mg daily (n=65), each in combination with placebo. Patients received treatment for 24 weeks, at which point momelotinib was available on an open-label basis.
At baseline, the median age was 71 years in the momelotinib arm and 72 years in the danazol arm. Most patients had primary myelofibrosis (60% and 70.8%, respectively), and most had a JAK2V617F mutation (74.6% and 78.5%, respectively).
The total symptom score (TSS) response rate at week 24 was the primary endpoint. Key secondary endpoints were transfusion independence at week 24 and splenic response rates (SRRs; of ≥25% and ≥35% reduction from baseline) at week 24.
Primary and key secondary endpoints were met. The TSS response rate was significantly higher with momelotinib than with danazol — 24.6% and 9.2%, respectively (P =.0095).
Patients in the momelotinib arm were more likely than those in the danazol arm to have a 25% or greater reduction in SRR from baseline to week 24 (40.0% vs 6.2%; P <.0001) or a 35% or greater reduction in SRR from baseline to week 24 (23.1% vs 3.1%; P =.0006).
The rate of transfusion independence at week 24 was 31% with momelotinib and 20% with danazol (P for noninferiority =.0064). Baseline rates of transfusion independence were 13.1% with momelotinib and 15.4% with danazol.
There was no significant difference in overall survival between the treatment arms overall (P =.3510) or up to week 24 (P =.0719).
During treatment, the rate of grade 3 or higher adverse events was 53.8% in the momelotinib arm and 64.6% in the danazol arm. Serious adverse events were reported in 34.6% and 40.0% of patients, respectively.
These results support the use of momelotinib as an effective treatment in patients with myelofibrosis, particularly those with anemia, according to Dr Verstovsek.
Disclosures: This research was supported by Sierra Oncology, Inc. The presenter declared affiliations with Sierra Oncology, Incyte, Roche, NS Pharma, Celgene/Bristol Myers Squibb, Gilead, Promedior, CTI BioPharma, Genentech, Blueprint Medicines, Novartis, Pharma Essentia, AstraZeneca, Italfarmaco, and Protagonist Therapeutics.
Verstovsek S, Vannucchi A, Gerds 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 EHA 2022; June 9-12, 2022. Abstract S195.