Red Blood Cell Transfusion Independence Status Is an Independent Predictor of Survival: A Post Hoc Time-Dependent Analysis of the Phase 3 Simplify-1, Simplify-2, and Momentum Trials (ASH 2023)
Momelotinib (MMB) is a Janus kinase (JAK) 1/JAK2/activin A receptor type 1 (ACVR1) inhibitor that has demonstrated spleen, symptom, and anemia benefits, including increases in hemoglobin (Hb) and reduction or elimination of red blood cell (RBC) transfusion requirements in pts with MF...Analyses were performed in the safety populations of S1 (N=430; MMB vs ruxolitinib [RUX], JAK inhibitor [JAKi] naive), S2 (N=156; MMB vs best available therapy [88.5% RUX], JAKi experienced), and MOMENTUM (N=195; MMB vs danazol, JAKi experienced)... These data demonstrate that when accounting for differences in known prognostic factors and effect modifiers as well as changes in RBC transfusion status over time, a consistent and statistically significant relationship was observed between transfusion status and OS across all 3 phase 3 MMB trials. Consistent with inclusion of transfusion status in DIPSS-plus risk assessment, these data validate TI status as a clinically relevant and meaningful endpoint that is prognostic for survival in JAKi-naive and JAKi-experienced disease settings.