48-week data from MOMENTUM phase III clinical trial show momelotinib maintained total symptom response, transfusion independence and splenic response in the majority of patients who responded to treatment during first 24 weeks
Additional analyses from MOMENTUM suggest that transfusion independence at week 24 was associated with overall survival
GSK plc (LSE/NYSE: GSK) today announced new 48-week data from the MOMENTUM phase III trial that showed a majority of patients treated with investigational momelotinib maintained their responses across key clinical measures including Total Symptom Score (TSS), Transfusion Independence (TI) rate, and Splenic Response Rate (SRR) in myelofibrosis patients previously treated with an approved Janus kinase (JAK) inhibitor. Additionally, new analyses from MOMENTUM showed that TI response with momelotinib at week 24 was associated with overall survival. These data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (10-13 December) in New Orleans.

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “Myelofibrosis patients have significant medical needs including progressive anaemia resulting from the disease and often exacerbated by currently approved treatments. The data presented today reinforce the potential of momelotinib as a treatment option with a favourable impact on myelofibrosis symptoms and spleen volume, as well as on blood transfusions due to anaemia.”

MOMENTUM is a global, randomised, double-blind phase III clinical trial of momelotinib (MMB) versus danazol (DAN) in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an approved JAK inhibitor. The study was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key manifestations of the disease: constitutional symptoms, blood transfusions (due to anaemia) and enlarged spleen. Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 and n=65, respectively). After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib. Early crossover to momelotinib was available for confirmed splenic progression.

Primary analysis at week 24 met the primary endpoint of TSS reduction of ?50% over the 28 days immediately before the end of week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form. It also met key secondary endpoints including TI rate for ?12 weeks immediately before the end of week 24 with haemoglobin levels ? 8 g/dL and SRR based on splenic volume reduction of ?35% at week 24 from baseline.

48-week follow-up data from MOMENTUM presented at ASH demonstrated the following (oral presentation #627):

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