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Momelotinib, a potent Janus kinase 1 and 2 (JAK1/2) inhibitor (JAKi) and an inhibitor of activin A receptor type I (ACVR1; also known as ALK-2), is being evaluated for the treatment of myelofibrosis (MF). The SIMPLIFY-1 trial (NCT01969838) compared momelotinib vs ruxolitinib in JAKi-naïve patients with MF where patients were randomized to receive momelotinib or ruxolitinib for 24 weeks, and open label momelotinib was available for all patients after Week 24.1
In an update of the SIMPLIFY-1 trial, which was recently published by Mesa et al.1 in the Leukemia & Lymphoma journal, retrospective, dynamic, and time-to-event analyses were performed on JAKi-naïve patients with MF. We summarize updated results below.
The MPN Hub previously provided an update of the SIMPLIFY-1 and SIMPLIFY-2 trials (best available therapy or ruxolitinib were used for comparison; NCT02101268). Momelotinib produced greater rates of transfusion independence, splenic response, and a reduction of constitutional symptoms in patients with myelofibrosis (MF) compared with ruxolitinib, which were associated with greater overall survival (OS).2,3
Table 1. Probability of zero transfusions (least squares mean) for the momelotinib and ruxolitinib cohorts*
BMF, bone marrow fibrosis; INT, international prognostic scoring system; MF, myelofibrosis; PET-MF, post-essential thrombocythemia myelofibrosis; PMF, primary myelofibrosis; PPV-MF; post-polycythemia vera myelofibrosis; RBC, red blood cell. |
||
Variable |
Momelotinib |
Ruxolitinib |
---|---|---|
Overall |
0.83 |
0.34 |
Baseline BMF |
||
Grade 1 |
0.96 |
0.73 |
Grade 2 |
0.88 |
0.43 |
Grade 3 |
0.76 |
0.25 |
Baseline INT |
||
1 |
0.97 |
0.79 |
2 |
0.89 |
0.45 |
Baseline high |
0.60 |
0.13 |
PET-MF |
0.79 |
0.28 |
PPV-MF |
0.90 |
0.48 |
PMF |
0.82 |
0.32 |
RBC units |
||
No baseline |
0.94 |
0.61 |
1–3 baseline |
0.32 |
0.05 |
4+ baseline |
0.06 |
0.01 |
Figure 1. Probability of achieving zero, <3, and <5 transfusion units by Week 24*
*Adapted from Mesa et al.1
The updated analysis of the randomized and open label treatment period from SIMPLIFY-1, further clarified the benefit of momelotinib for transfusion requirements in patients with MF when compared with ruxolitinib. Momelotinib is further being investigated in the phase III MOMENTUM trial (NCT04173494), which recruited symptomatic and anemic patients previously treated with an approved JAKi. Earlier this year, it was announced that the MOMENTUM trial met its primary and major secondary endpoints; read more here.
Click here to watch a video interview with Ruben A. Mesa, entitled ‘SIMPLIFY-1+2 trial: What is the long-term benefit of momelotinib treatment in R/R MF?’
Click here to watch a video interview with Ruben A. Mesa, entitled ‘How does transfusion independence impact survival outcomes with momelotinib in MF?’
References
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