{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T18:37:09Z","timestamp":1793731029779,"version":"4.6.1"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (R\/R Ph<jats:sup>+<\/jats:sup> ALL) and chronic myeloid leukemia in the blast phase (CML-BP) are associated with poor prognoses. Olverembatinib (HQP1351), a novel third-generation tyrosine kinase inhibitor (TKI), has shown promising efficacy and safety in clinical trials against nearly all BCR-ABL1 kinase mutations, including <jats:italic>T315I<\/jats:italic>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data were collected and analyzed to evaluate the efficacy and safety of olverembatinib-based therapy for advanced Ph<jats:sup>+<\/jats:sup> leukemia. The primary outcome was the overall response rate at 28 days. Secondary outcomes included overall survival (OS), event-free survival (EFS), disease-free survival (DFS), the proportion of patients undergoing allo-HSCT, and adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 59 patients participated in the study, including 40 patients with Ph<jats:sup>+<\/jats:sup> ALL and 19 with CML-BP. Among them, 36 (61.0%) were men, and 23 (39.0%) were women. The median age was 39 years (interquartile range [IQR], 30\u201348), and the median follow-up duration was 7.8 months (IQR, 4.1\u201311.3). A total of 16 (27.1%) and 11 patients (18.6%) had received treatment with two and \u2265 3 prior TKIs, respectively. Additionally, 19 patients (33.9%) had been treated with ponatinib. In a cohort of 19 CML patients, 12 (63.2%) achieved CR\/CRi by day 28. Five (26.3%) achieved a complete cytogenetic response with a median duration of 2.9 months, and two (10.5%) achieved a major molecular response with a median duration of 5.5 months. Among 40 evaluated ALL patients, 37 (92.5%) achieved CR\/CRi by day 28, 30 (75.0%) attained MRD negativity, and 22 (55.0%) achieved CMR. The probabilities of DFS, EFS, and OS at 12 months were 80.3% (95% confidence interval [CI]: 61.0%\u201390.7%), 80.2% (95% CI: 61.0%\u201390.7%), and 93.3% (95% CI: 75.8%\u201398.3%) for patients with R\/R Ph<jats:sup>+<\/jats:sup> ALL, compared to 52.0% (95% CI: 17.7%\u201378.0%), 23.0% (95%CI, 4.2%-50.6%), and 75.6% (95% CI: 37.7%\u201392.3%) for those with CML-BP. The prevalent treatment-related nonhematologic adverse events, primarily classified as grade 1\/2, included skin hyperpigmentation, proteinuria, increased liver enzyme levels, and hypertriglyceridemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Olverembatinib-based therapy demonstrated significant efficacy and manageable toxicity in patients with advanced Ph<jats:sup>+<\/jats:sup> leukemia.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fimmu.2025.1546371","type":"journal-article","created":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T05:39:18Z","timestamp":1747201158000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["Olverembatinib (HQP1351)-based therapy in adults with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia in blast phase: results from a real-world study"],"prefix":"10.3389","volume":"16","author":[{"given":"Ziyu","family":"Wen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhi","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu","family":"Ye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiping","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fen","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Xuan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofang","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Jin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuan","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoli","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qifa","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongsheng","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,5,14]]},"reference":[{"key":"B1","doi-asserted-by":"crossref","DOI":"10.1080\/14737140.2020.1832890","article-title":"Treatment and outcome of Philadelphia chromosome-positive acute lymphoblastic leukemia in adults after relapse","volume":"20","author":"Balsat","year":"2020","journal-title":"Expert Rev Anticancer Ther"},{"key":"B2","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1038\/s41375-022-01736-5","article-title":"Pathogenesis and management of accelerated and blast phases of chronic myeloid leukemia","volume":"37","author":"Senapati","year":"2023","journal-title":"Leukemia"},{"key":"B3","doi-asserted-by":"crossref","DOI":"10.1111\/bjh.18370","article-title":"Treatment of blast phase chronic myeloid leukaemia: A rare and challenging entity","volume":"199","author":"Copland","year":"2022","journal-title":"Br J haematol"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2016.1190335","article-title":"How has treatment changed for blast phase chronic myeloid leukemia patients in the tyrosine kinase inhibitor era? 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