Frontiers in immunology · 2025
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.
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Wen Ziyu, Liu Zhi, Ye Xu, Fan Zhiping, Lin Ren, Huang Fen, Xuan Li, Li Xiaofang, Jin Hua, Dai Min, Sun Jing, Zhou Xuan, Wang Qiang, Liu Xiaoli, Liu Qifa, Zhou Hongsheng, Xu Na
Аннотация
BACKGROUND: Relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (R/R Ph+ 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 T315I.
METHODS: Data were collected and analyzed to evaluate the efficacy and safety of olverembatinib-based therapy for advanced Ph+ 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.
RESULTS: A total of 59 patients participated in the study, including 40 patients with Ph+ 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], 30-48), and the median follow-up duration was 7.8 months (IQR, 4.1-11.3). A total of 16 (27.1%) and 11 patients (18.6%) had received treatment with two and ≥ 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%-90.7%), 80.2% (95% CI: 61.0%-90.7%), and 93.3% (95% CI: 75.8%-98.3%) for patients with R/R Ph+ ALL, compared to 52.0% (95% CI: 17.7%-78.0%), 23.0% (95%CI, 4.2%-50.6%), and 75.6% (95% CI: 37.7%-92.3%) 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.
CONCLUSIONS: Olverembatinib-based therapy demonstrated significant efficacy and manageable toxicity in patients with advanced Ph+ leukemia.
METHODS: Data were collected and analyzed to evaluate the efficacy and safety of olverembatinib-based therapy for advanced Ph+ 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.
RESULTS: A total of 59 patients participated in the study, including 40 patients with Ph+ 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], 30-48), and the median follow-up duration was 7.8 months (IQR, 4.1-11.3). A total of 16 (27.1%) and 11 patients (18.6%) had received treatment with two and ≥ 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%-90.7%), 80.2% (95% CI: 61.0%-90.7%), and 93.3% (95% CI: 75.8%-98.3%) for patients with R/R Ph+ ALL, compared to 52.0% (95% CI: 17.7%-78.0%), 23.0% (95%CI, 4.2%-50.6%), and 75.6% (95% CI: 37.7%-92.3%) 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.
CONCLUSIONS: Olverembatinib-based therapy demonstrated significant efficacy and manageable toxicity in patients with advanced Ph+ leukemia.