Momelotinib met all primary and key secondary endpoints
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New hope for myelofibrosis patients was announced in August 2022, after the acceptance of the new drug application (NDA) for momelotinib. The approval of the submitted NDA came after significant results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). The primary analysis data from the MOMENTUM trial were recently presented at the 2022 American Society of Clinical Oncology Annual Meeting and the European Hematology Association 2022 Hybrid Congress.
MOMENTUM is a global, randomized, double-blind phase 3 clinical trial of momelotinib versus danazol in patients with Myelofibrosis who were symptomatic and anemic and had been previously treated with an FDA-approved JAK inhibitor.
The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease, including symptoms, blood transfusions – due to anemia – and splenomegaly – enlarged spleen.
The trial’s primary efficacy endpoint was TSS reduction of more than 50% over the 28 days immediately before the end of week 24 compared to baseline TSS.
Regarding safety, grade 3 or higher adverse effects (AEs) were experienced by 53.8% of those in the momelotinib arm vs 64.6% of those in the control arm; serious AEs occurred in 34.6% and 40.0% of patients, respectively.
Momelotinib was most recently developed by Sierra Oncology, which GSK acquired in July 2022, building on GSK’s experience in hematology and portfolio of specialty medicines and vaccines. Momelotinib is not currently approved in any market.
Currently, Ruxolitinib is approved for treating symptoms and splenomegaly in Myelofibrosis for high and intermediate-2 risk patients. Some countries extended the approval to intermediate-1 risk too.
For healthcare professionals interested in learning more about Myelofibrosis, you can start your free course here.
