Haematologica (Apr 2025)

Optimizing olverembatinib dose in chronic phase chronic myeloid leukemia

  • Xiaoshuai Zhang,
  • Yunfan Yang,
  • Bingcheng Liu,
  • Xin Du,
  • Xiaodong Wang,
  • Huanling Zhu,
  • Lu Yu,
  • Zongru Li,
  • Shasha Zhao,
  • Linhua Yang,
  • Yanping Ma,
  • Li Meng,
  • Yanqing Zhang,
  • Guohui Li,
  • Lijie Yang,
  • Baohong Wang,
  • Xuehong Ran,
  • Jian Huang,
  • Na Gao,
  • Qin Wen,
  • Yan Wen,
  • Yuxia Zhao,
  • Yu Zhu,
  • Yanqiu Han,
  • Zhenfang Liu,
  • Xin Du,
  • Jianyu Weng,
  • Robert Peter Gale,
  • Li Zhou,
  • Yanli Zhang,
  • Qian Jiang

DOI
https://doi.org/10.3324/haematol.2024.287116
Journal volume & issue
Vol. 999, no. 1

Abstract

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Optimizing olverembatinib dose in people with chronic phase chronic myeloid leukemia (CML) is important to increase safety without compromising efficacy. We designed a multi-center retrospective study comparing safety and efficacy of olverembatinib between the recommended dose of 40 mg every other day (QOD; N = 216) and a reduced dose of 30 mg QOD (N = 66) in subjects failing other tyrosine kinase-inhibitors (TKIs). The cohorts were similar in baseline co-variates and adjusted for by propensity score matching (PSM). There were no significant differences in cytogenetic and molecular responses, as well as outcomes between the 2 dose cohorts. However, the proportion of subjects receiving the original olverembatinib dose at the last follow-up was significantly higher in the 30 mg cohort (64% [95%Confidence Interval [CI], 53, 75%] versus 44% [37,51%]; p = 0.004). Also, the proportion of subjects receiving a reduced dose or permanently discontinuing because of adverse event was significantly lower in the 30 mg cohort (21% [9, 33%] versus 41% [34, 48%]; p = 0.003). In summary, olverembatinib, 30 mg QOD starting dose is as effective as a 40 mg starting dose but better tolerated in persons with chronic phase CML failing other TKIs.