Efficacy and safety of ruxolitinib in Asian patients with myelofibrosis

Chul Won Jung, Lee Yung Shih, Zhijian Xiao, Jin Jie, Hsin An Hou, Xin Du, Ming Chung Wang, Seonyang Park, Ki Seong Eom, Kenji Oritani, Shinichiro Okamoto, Tetsuzo Tauchi, Jin Seok Kim, Daobin Zhou, Shigeki Saito, Junmin Li, Hiroshi Handa, Li Jianyong, Kohshi Ohishi, Ming HouWu Depei, Katsuto Takenaka, Ting Liu, Yu Hu, Taro Amagasaki, Kazuo Ito, Prashanth Gopalakrishna, Koichi Akashi

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Myelofibrosis is characterized by progressive cytopenias, bone marrow fibrosis, splenomegaly and severe constitutional symptoms. In the phase 3 Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment (COMFORT) studies, ruxolitinib, a potent Janus kinase 1 (JAK1)/JAK2 inhibitor, provided substantial improvements in splenomegaly, symptoms, quality-of-life measures and overall survival compared with placebo or best available therapy. No assessments of the efficacy and safety of ruxolitinib have been conducted in Asian patients. Here, we describe results from an open-label, single-arm, phase 2 trial evaluating ruxolitinib in Asian patients with myelofibrosis (n = 120). The primary endpoint was met, with 31.7% of patients achieving a ≥ 35% reduction from baseline spleen volume at week 24. As measured by the 7-day Myelofibrosis Symptom Assessment Form v2.0, 49% of patients achieved a ≥ 50% reduction from baseline in total symptom score. Adverse events were consistent with those seen in the COMFORT studies. Ruxolitinib was well tolerated in Asian patients with myelofibrosis and provided substantial reductions in splenomegaly and improvements in symptoms.

Original languageEnglish
Pages (from-to)2067-2074
Number of pages8
JournalLeukemia and Lymphoma
Volume56
Issue number7
DOIs
Publication statusPublished - 2015 Jul 1

Keywords

  • Asian patient population
  • JAK1/JAK2 inhibitor
  • Myelofibrosis
  • Phase 2

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Jung, C. W., Shih, L. Y., Xiao, Z., Jie, J., Hou, H. A., Du, X., Wang, M. C., Park, S., Eom, K. S., Oritani, K., Okamoto, S., Tauchi, T., Kim, J. S., Zhou, D., Saito, S., Li, J., Handa, H., Jianyong, L., Ohishi, K., ... Akashi, K. (2015). Efficacy and safety of ruxolitinib in Asian patients with myelofibrosis. Leukemia and Lymphoma, 56(7), 2067-2074. https://doi.org/10.3109/10428194.2014.969260