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Olverembatinib 2L — Olverembatinib (HQP1351), second-line chronic-phase CML

Abstract: 6510 · Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Rapid Oral), Sat May 30, 2026, 1:21–1:27 p.m. CT · Presenter: Weiming Li, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China · Embargo: May 30, 2026

At a glance

  • Sponsor: Ascentage Pharma Group International
  • PI / presenter: Weiming Li, MD (Union Hospital, Tongji Medical College, HUST, Wuhan, China)
  • NCT ID: not reported in ASCO 2026 disclosures
  • Phase: Investigator-style single-arm registration-supporting study (phase not explicitly stated)
  • Design: Single-arm, multicenter, open-label; conducted in China
  • N: 42 evaluable patients
  • Primary endpoint(s): Cytogenetic/molecular response (CCyR, MMR)
  • Comparator: None (single-arm)
  • Indication: Chronic-phase chronic myeloid leukemia (CML-CP)
  • Line: Second line (resistant/intolerant to first-line TKIs)

Headline result

Among 42 evaluable CML-CP patients treated with olverembatinib as second-line therapy, the complete cytogenetic response (CCyR) rate reached 91.3% and the major molecular response (MMR) rate reached 60.9% by cycle 24; best-response rates at the data cutoff were 76.2% (CCyR) and 47.6% (MMR). In the subgroup of 32 patients who had failed a first-line second-generation TKI, 81.3% achieved CCyR and 50% achieved MMR. No comparator arm, HR, or p-value applies (single-arm design). Treatment-related adverse events occurred in 89.4% of patients, mostly low-grade and manageable — most commonly skin hyperpigmentation, hyperuricemia, and increased creatine phosphokinase; grade ≥3 hematologic toxicities were recoverable with supportive care, and no new safety signals were identified.

Mechanism / class

Olverembatinib (HQP1351) is a third-generation oral BCR-ABL1 tyrosine kinase inhibitor with activity against a broad spectrum of resistance mutations, including the T315I mutation. It is approved in China for TKI-resistant CML (including T315I-mutant CP- and AP-CML) and is in global development by Ascentage Pharma.

Practice-changing?

Pending. Strong cycle-24 CCyR/MMR rates support olverembatinib as an active second-line option in CML-CP, including after second-generation TKI failure, but the single-arm design, small N (42), and China-only population limit immediate practice change in regions where the drug is not yet approved second-line. Confirmatory/comparative data would strengthen the case.

  • Other ASCO 2026 trials: olverembatinib and other Ascentage data (see ./ for same-sponsor heme abstracts)

Sources

  • ASCO 2026 Abstract 6510 (Hematologic Malignancies—Leukemia, MDS, and Allotransplant; Rapid Oral, May 30, 2026)
  • Ascentage Pharma press release (May 31, 2026): https://www.globenewswire.com/news-release/2026/05/31/3303966/0/en/Ascentage-Pharma-Presents-Updated-Clinical-Data-for-Olverembatinib-as-Second-Line-Therapy-in-CML-CP-at-ASCO-2026.html
  • Ascentage Pharma press release (May 22, 2026): https://www.globenewswire.com/news-release/2026/05/22/3299861/0/en/Ascentage-Pharma-Releases-Latest-Clinical-Data-from-Multiple-Trials-at-ASCO-2026.html
  • StockTitan coverage: https://www.stocktitan.net/news/AAPG/ascentage-pharma-presents-updated-clinical-data-for-olverembatinib-kf28gym56qz3.html