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Olverembatinib: real progress in BCR::ABL1 leukemia?

Vivian G Oehler1, Ariel Leyte-Vidal2, Ivan J Huang3

  • 1Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA, USA; Department of Medicine, Division of Hematology and Oncology, University of Washington, Seattle, WA. voehler@fredhutch.org.

Haematologica
|July 9, 2026
PubMed

Insights

Olverembatinib is a third-generation tyrosine kinase inhibitor effective against resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It shows promise for patients with T315I mutations and those resistant to other TKIs.

Area of Science:

  • Oncology
  • Pharmacology
  • Hematology

Background:

  • Chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) are driven by BCR::ABL1.
  • Tyrosine kinase inhibitors (TKIs) are standard treatments, but resistance, particularly the T315I mutation, necessitates novel therapies.
  • Olverembatinib (HQP1351) is a third-generation TKI designed to overcome resistance mechanisms.

Purpose of the Study:

  • To review the safety, tolerability, and efficacy of olverembatinib in CML and Ph+ ALL.
  • To evaluate olverembatinib's role in treating TKI-resistant CML, including T315I mutations.
  • To discuss the potential of olverembatinib in first-line Ph+ ALL treatment.

Main Methods:

  • Review of clinical trial data from China and ongoing global studies (including US Phase 1b).
  • Analysis of safety and efficacy endpoints in adult patients with CML and Ph+ ALL.
  • Assessment of olverembatinib's binding to active and inactive conformations of ABL1 and BCR::ABL1.

Main Results:

  • Olverembatinib is approved in China for TKI-resistant CML (CP/AP) with T315I mutation and for imatinib/2G TKI-resistant CP CML.
  • Received breakthrough therapy designation for first-line Ph+ ALL in combination with chemotherapy.
  • Global clinical studies are ongoing, with US Phase 1b results anticipated in 2025.

Conclusions:

  • Olverembatinib demonstrates significant efficacy and tolerability in TKI-resistant CML and Ph+ ALL.
  • It represents a crucial therapeutic option for patients with resistance mutations like T315I.
  • Further global data will solidify its role in hematologic malignancies and guide future development.

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