Are you familiar with the Momelotinib (JAK1/2i/ACVR1i) myelofibrosis SIMPLIFY-1 and SIMPLIFY-2 clinical data and the design of the MOMENTUM clinical trial?

What do you expect the MOMENTUM trial TSS primary endpoint to be for the Momelotinib arm, and the Danazol arm, respectively (0-100%)? The primary endpoint is defined as the percentage of patients that have a Total Symptom Score (TSS) response at Week 24, which is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS.

• Momelotinib (and why?)
• Danazol (and why?)
  

What do you expect the MOMENTUM trial TI secondary endpoint to be for the Momelotinib arm, and the Danazol arm, respectively (0-100%)? The TI secondary endpoint is defined as the percentage of patients with TI status at the end of Week 24. TI is defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥ 12 weeks immediately prior to the end of Week 24, with Hgb levels ≥ 8 g/dL.

• Momelotinib (and why?)
• Danazol (and why?)

What do you expect the MOMENTUM trial SRR secondary endpoint to be for the Momelotinib arm, and the Danazol arm, respectively (0-100%)? The SRR secondary endpoint is defined as the percentage of patients who have splenic response (reduction in spleen volume of ≥ 35% from baseline) at the end of Week 24.Please note that MOMENTUM enrollment requires any ongoing JAKi therapy to be tapered, followed by a 2-week nontreatment interval prior to initiating study treatment.

• Momelotinib (and why?)
• Danazol (and why?)

Where do you practice?