Olverembatinib in accelerated-phase chronic myeloid leukemia: efficacy and safety evaluation

We studied 130 consecutive subjects who presented with (N=29) or transformed to (N=101) accelerated-phase chronic myeloid leukemia (CML) and who received olverembatinib. Sixty-two were in second chronic phase. All failed ≥1 tyrosine kinase inhibitor (TKI) and 91 had BCR::ABL1T315I. Median follow-up was 28 months (interquartile range, 10-74 months). The 6-year cumulative incidences of major cytogenetic response (MCyR), complete cytogenetic response, major molecular response and molecular response 4.0 were 59% (95% confidence interval [CI]: 49- 69), 53% (95% CI: 42-62), 52% (95% CI: 41-62) and 42% (95% CI: 31- 53), respectively. The 6-year probabilities of transformation-free survival (TFS), CML-related survival and survival were 81% (95% CI: 72-90), 76% (95% CI: 67-87%) and 71% (95% CI: 61-82), respectively. In multi-variable analyses, an interval from diagnosis of CML to olverembatinib start <29 months, failure to achieve complete hematologic response on prior TKI therapy, hemoglobin concentration <98 g/L, blood and/or bone marrow blasts ≥8%, and/or high-risk additional chromosome abnormalities at the start of olverembatinib therapy, as well as not achieving early MCyR on olverembatinib correlated with worse outcomes. RUNX1 and STAT5A variants were significantly associated with worse TFS in the 82 subjects with targeted DNA-sequencing data. There were acceptable treatment-related adverse events. We conclude olverembatinib is effective and tolerable in subjects in accelerated-phase CML failing prior TKI therapy.

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Journal
Haematologica
Published
2025-10-16
DOI
https://doi.org/10.3324/haematol.2025.288249
Primary Topic
Chronic Myeloid Leukemia Treatments
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article
Field-Weighted Citation Impact
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article

Olverembatinib in accelerated-phase chronic myeloid leukemia: efficacy and safety evaluation

Jianyu Weng, Chunshui Liu, Haiguo Zhang, Mengyao Yuan et al.
Haematologica
Chronic Myeloid Leukemia Treatments
article

Olverembatinib in accelerated-phase chronic myeloid leukemia: efficacy and safety evaluation

Jianyu Weng, Chunshui Liu, Haiguo Zhang, Mengyao Yuan, Yun Zeng, Xin Du, Zhenfang Liu, Zongru Li, Xiaojun Huang, Shasha Zhao, Qing Leng, Yanping Ma, Robert Peter Gale, Lu Yu, Xiaodong Wang, Yanli Zhang, Linhua Yang, Jiang Qian, Weiming Li, Li Zhou, Baohong Wang, Wen Qin, Bingcheng Liu, Li Meng, Xianqi Feng, Qing-Xian Bai, Xuehong Ran, Yanqiu Han
article en

Abstract

We studied 130 consecutive subjects who presented with (N=29) or transformed to (N=101) accelerated-phase chronic myeloid leukemia (CML) and who received olverembatinib. Sixty-two were in second chronic phase. All failed ≥1 tyrosine kinase inhibitor (TKI) and 91 had BCR::ABL1T315I. Median follow-up was 28 months (interquartile range, 10-74 months). The 6-year cumulative incidences of major cytogenetic response (MCyR), complete cytogenetic response, major molecular response and molecular response 4.0 were 59% (95% confidence interval [CI]: 49- 69), 53% (95% CI: 42-62), 52% (95% CI: 41-62) and 42% (95% CI: 31- 53), respectively. The 6-year probabilities of transformation-free survival (TFS), CML-related survival and survival were 81% (95% CI: 72-90), 76% (95% CI: 67-87%) and 71% (95% CI: 61-82), respectively. In multi-variable analyses, an interval from diagnosis of CML to olverembatinib start <29 months, failure to achieve complete hematologic response on prior TKI therapy, hemoglobin concentration <98 g/L, blood and/or bone marrow blasts ≥8%, and/or high-risk additional chromosome abnormalities at the start of olverembatinib therapy, as well as not achieving early MCyR on olverembatinib correlated with worse outcomes. RUNX1 and STAT5A variants were significantly associated with worse TFS in the 82 subjects with targeted DNA-sequencing data. There were acceptable treatment-related adverse events. We conclude olverembatinib is effective and tolerable in subjects in accelerated-phase CML failing prior TKI therapy.

HaematologicaVol. 111(3)
Qingdao University (CN), Army Medical University (CN), Shanxi Medical University (CN), Jilin University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Kunming Medical University (CN), Ruijin Hospital (CN), Second Affiliated Hospital of Inner Mongolia Medical University (CN), Weifang People's Hospital (CN), Affiliated Hospital of Qingdao University (CN), Xinqiao Hospital (CN), Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN), First Affiliated Hospital of Kunming Medical University (CN), Peking University People's Hospital (CN), First Hospital of Jilin University (CN), First Affiliated Hospital of GuangXi Medical University (CN), Wuhan Union Hospital (CN), Inner Mongolia Medical College Hospital (CN), Second Hospital of Shanxi Medical University (CN), Jining First People's Hospital (CN), Henan Cancer Hospital (CN), Guangdong Academy of Medical Sciences (CN), Shanghai Institute of Hematology (CN), Institute of Hematology & Blood Diseases Hospital (CN), Xijing Hospital (CN), Tongji Hospital (CN), Center for Life Sciences (CN), Qingdao Eighth People's Hospital (CN), Anshan Hospital (CN), Inner Mongolia Medical University (CN), Imperial College London (GB)
National Institute for Health and Care Research
Openalex Percentile: Top 63%
Chronic Myeloid Leukemia Treatments
DOIOpen Access PDFOpenAlex
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