Shots:

• The P-III (MOMENTUM) trial evaluates momelotinib (MMB) vs danazol (DAN) in a ratio (2:1) in 195 patients with myelofibrosis
• The trial met its 1EPs & 2EPs i.e., TSS reduction of ≥50% over the 28 days before the end of 24wk. over baseline TSS, TI rate for ≥12wks. with Hb levels ≥8g/dL and SRR based on splenic volume reduction of ≥35% @24wk.
• Patients maintained their responses across clinical measures incl. TSS, TI rate & SRR, 20% of non-responding patients with MMB achieved a TSS response; 29% with new TSS response treated with DAN & crossed over to MMB @48wk.; 24 out of 30 patients with splenic response @24wks., TI response with MMB was associated with OS @24wk. The NDA & MAA for MMB is under the US FDA & EMA’s review

Ref: GSK | Image: GSK