Robust Overall Survival and Sustained Efficacy Outcomes during Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and Previously JAK Inhibitor Treated Intermediate/High Risk Myelofibrosis Patients (original) (raw)

Introduction: Momelotinib (MMB) is a potent JAK1, JAK2 and ACVR1 inhibitor with clinical activity against the three hallmark features of myelofibrosis (MF), namely anemia, constitutional symptoms and splenomegaly, across the continuum of intermediate/high risk MF patients whether JAKi--naïve or previously JAKi-treated as demonstrated in the previously conducted Phase 3 SIMPLIFY-1 & -2 clinical trials (S1, S2). S1 was conducted in JAKi-naïve MF patients (n=432) randomized 1:1 to MMB or ruxolitinib (RUX) over a 24-week double-blind dosing period. S2 was conducted in MF patients who experienced hematological toxicity during prior RUX therapy (n=156) randomized 2:1 to MMB or best available therapy (BAT; consisting of RUX in 88% of patients) over a 24-week open-label dosing period. In both trials, following the 24-week randomized treatment (RT) period, patients originally randomized to MMB could continue MMB therapy (MMB→MMB) and those randomized to RUX/BAT were eligible to cross-over to...