ArticleAnnals of hematology2026
Real-world outcomes of ponatinib in heavily pretreated patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.
Article in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03709017 (Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"), which is not on this map. Not yet cited in PubMed.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
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0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To evaluate the real-world efficacy and safety of ponatinib, we conducted a multicenter, prospective post-marketing surveillance study in patients with chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), who were resistant or intolerant to prior tyrosine kinase inhibitors (TKIs) or harbored the T315I mutation. A total of 148 patients were enrolled across 24 sites: 115 with CML (92 CP-CML, 12 AP-CML, 11 BP-CML) and 33 with Ph + ALL. Ponatinib was administered as third-line therapy in 70 patients (47.3%), and 127 (85.8%) initiated treatment at 45 mg once daily. Sixty-three patients (42.6%) began ponatinib due to resistance or intolerance to prior TKIs. In CP-CML, the overall major molecular response (MMR) rate was 43.2% (35/81), with a cumulative MMR incidence of 23.9% at week 24 among patients without prior MMR. In Ph + ALL, the overall MMR and complete cytogenetic response (CCyR) rates were 82.4% (14/17) and 75.0% (3/4), respectively. CP-CML patients receiving ponatinib as earlier-line therapy achieved higher MR4.5 rates than those treated later (47.4% vs. 16.1%, p = 0.011). The most common adverse drug reactions were rash (21.6%, 32/148), hypertension (12.2%, 18/148), and pyrexia (10.1%, 15/148); two vascular occlusive events occurred. Ponatinib showed favorable real-world efficacy and manageable safety in Korean patients. Early, high-dose therapy suggests a trend toward deep molecular responses, supporting its clinical benefit in real-world practice. (ClinicalTrials.gov Identifier: NCT03709017; registered October 15, 2018).
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