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Question 1 of 2
What percentage of patients discontinued momelotinib treatment due to thrombocytopenia across the MOMENTUM, SIMPLIFY-1, and SIMPLIFY-2 trials?
A
B
C
D
Momelotinib, an oral inhibitor of Janus kinase 1, Janus kinase 2, and activin A type 1 receptor (ACVR1), is a U.S. Food and Drug Administration (FDA) approved therapy for the treatment of patients with anemic myelofibrosis (MF). Patients with MF often also present with thrombocytopenia, which is associated with poorer clinical outcomes.
The efficacy of momelotinib was evaluated by Kiladjian et al.1 in a post-hoc subgroup analysis of data from MOMENTUM, SIMPLIFY-1, and SIMPLIFY-2, previously reported by the MPN Hub.
Patients from the three included studies with thrombocytopenia, characterized by a platelet count <100 × 109 /L, were included. The design of this multi-trial analysis is presented in Figure 1.
Figure 1. Post hoc analysis design*
BAT, best available therapy; JAKi, Janus kinase inhibitor.
*Adapted from Kiladjian, et al.1
To assess momelotinib efficacy in the <100 × 109/L patient subgroups, data was collected at Week 24 in the following measures:
Response rates stratified by baseline platelet count for each trial are presented in Figure 2.
Figure 2. Response rates for SV35, transfusion independence, and TSS*
BAT, best available therapy; SVR35, spleen volume reduction ≥35%; TSS, Total Symptom Score.
*Adapted from Kiladjian, et al.1
OS data was collected at various time points and compared with the overall populations of each trial; this data is presented in Table 1.
Table 1. OS data for SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM*
BAT, best available therapy; OS, overall survival. |
|||
OS, % |
<100 × 109/L |
<50 × 109/L |
Overall |
---|---|---|---|
SIMPLIFY-1 |
|||
Momelotinib > momelotinib |
|
|
|
3 years |
56.7 |
— |
71.1 |
6 years |
37.8 |
— |
54.3 |
Ruxolitinib > momelotinib |
|
— |
|
3 years |
53.3 |
— |
71.1 |
6 years |
26.6 |
— |
53.3 |
SIMPLIFY-2 |
|||
Momelotinib > momelotinib |
|
— |
|
3 years |
59.8 |
— |
49.9 |
6 years |
59.8 |
— |
42.8 |
BAT > momelotinib |
|
— |
|
3 years |
65.5 |
— |
53.9 |
6 years |
54.6 |
— |
46.7 |
MOMENTUM |
|||
Momelotinib > momelotinib |
|
|
|
6 months |
86.2 |
94.4 |
88.1 |
12 months |
74.7 |
75.6 |
74.0 |
Danazol > momelotinib |
|
|
|
6 months |
82.1 |
59.8 |
79.9 |
12 months |
71.0 |
47.9 |
73.6 |
Grade ≥3 thrombocytopenia and hemorrhage were used as key safety indicators, alongside thrombocytopenia resulting in discontinuation or dose reduction (Table 2).
Table 2. Safety outcomes*
Patients, % |
MOMENTUM |
SIMPLIFY-1 |
SIMPLIFY-2 |
|||
---|---|---|---|---|---|---|
|
Momelotinib |
Danazol |
Momelotinib |
Ruxolitinib |
Momelotinib |
BAT |
AE, adverse events; BAT, best available therapy. |
||||||
Grade ≥3 AEs |
|
|
|
|
|
|
Thrombocytopenia |
33 |
21 |
17 |
22 |
19 |
7 |
Hemorrhage |
6 |
0 |
6 |
4 |
7 |
0 |
Thrombocytopenia resulting in dose reduction or discontinuation |
12 |
5 |
17 |
— |
— |
— |
Overall, momelotinib demonstrated a clinical benefit in patients with MF and thrombocytopenia compared with ruxolitinib, danazol, and best available therapy. The safety profile was comparable to the overall population. Notably, this post hoc analysis used trials not initially designed for platelet count subgroup analysis; however, it highlighted the potential of momelotinib as a treatment option for further investigation in patients with MF and thrombocytopenia.
References
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