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Introduction <p>This post hoc analysis investigated the efficacy and safety of momelotinib in the Asian subpopulation of MOMENTUM (NCT04173494).</p> Methods <p>Patients were randomized 2:1 to momelotinib 200&#xa0;mg once daily (QD) plus danazol placebo (momelotinib group) or danazol 600&#xa0;mg QD plus momelotinib placebo (danazol group) for 24&#xa0;weeks (W), after which they could receive open-label momelotinib or danazol. Primary endpoint: W24 total symptom score (TSS) response rate (≥ 50% reduction from baseline). W24 key secondary endpoints: transfusion independence rate; mean TSS change from baseline; splenic response rate; rate of zero transfusions.</p> Results <p>Seventeen Asian patients with myelofibrosis were included (momelotinib: <i>n</i> = 11; danazol: <i>n</i> = 6). TSS response rate at W24 was 36.4% with momelotinib and 0% with danazol. Secondary endpoints favored momelotinib and were consistent with the intention-to-treat population. Grade ≥ 3 treatment-emergent adverse events were reported in 36.4 and 66.7% of the momelotinib and danazol groups, respectively, including one grade ≥ 3 anemia in the momelotinib group. Treatment interruption and/or dose reduction occurred in 18.2 and 16.7% of the momelotinib and danazol groups, respectively. Two danazol-treated patients discontinued study treatment.</p> Conclusion <p>In the Asian subpopulation of MOMENTUM, momelotinib improved myelofibrosis-associated symptoms, anemia measures, and spleen response, with generally favorable safety versus danazol.</p>

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Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月21日

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  • Sung-Soo Yoon,
  • Chih Cheng Chen,
  • Sung-Eun Lee,
  • Hung Chang,
  • June-Won Cheong,
  • Hsin-An Hou,
  • Won Sik Lee,
  • Sung-Nam Lim,
  • Joon Ho Moon,
  • Kiat Hoe Ong,
  • Yi Dai,
  • Chang Liu,
  • Jun Kawashima,
  • Yeow Tee Goh

摘要

Introduction

This post hoc analysis investigated the efficacy and safety of momelotinib in the Asian subpopulation of MOMENTUM (NCT04173494).

Methods

Patients were randomized 2:1 to momelotinib 200 mg once daily (QD) plus danazol placebo (momelotinib group) or danazol 600 mg QD plus momelotinib placebo (danazol group) for 24 weeks (W), after which they could receive open-label momelotinib or danazol. Primary endpoint: W24 total symptom score (TSS) response rate (≥ 50% reduction from baseline). W24 key secondary endpoints: transfusion independence rate; mean TSS change from baseline; splenic response rate; rate of zero transfusions.

Results

Seventeen Asian patients with myelofibrosis were included (momelotinib: n = 11; danazol: n = 6). TSS response rate at W24 was 36.4% with momelotinib and 0% with danazol. Secondary endpoints favored momelotinib and were consistent with the intention-to-treat population. Grade ≥ 3 treatment-emergent adverse events were reported in 36.4 and 66.7% of the momelotinib and danazol groups, respectively, including one grade ≥ 3 anemia in the momelotinib group. Treatment interruption and/or dose reduction occurred in 18.2 and 16.7% of the momelotinib and danazol groups, respectively. Two danazol-treated patients discontinued study treatment.

Conclusion

In the Asian subpopulation of MOMENTUM, momelotinib improved myelofibrosis-associated symptoms, anemia measures, and spleen response, with generally favorable safety versus danazol.