ArticleTherapeutic advances in hematology2025
Real-world treatment outcome and toxicity analysis of inotuzumab ozogamicin in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia: multicenter prospective observational study.
Article in Therapeutic advances in hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Adults with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (BCP-ALL) have dismal prognoses, underscoring the need for effective salvage therapies. Inotuzumab ozogamicin (INO) and blinatumomab (BLIN) have demonstrated efficacy in achieving complete remission (CR) and measurable residual disease (MRD) response. Objectives: We tried to evaluate the clinical outcomes and toxicities of INO in adults with R/R BCP-ALL. Design: Prospective observational multicenter study. Methods: A total of 100 patients (25 Ph-positive, 75 Ph-negative) received INO (0.8 mg/m Results: Among the cohort, 7 patients were primary refractory (4 post-BLIN), 36 relapsed after chemotherapy (23 post-BLIN), and 57 relapsed after allo-HCT (23 post-BLIN). Extramedullary relapse occurred in 39% of patients. After the first cycle, 60% achieved CR or CR with incomplete hematologic recovery; the overall best response rate after two cycles was 67%, with MRD negativity achieved in 63.1%. Thirty-nine patients (58.2%) underwent allo-HCT. Early mortality occurred in 12%, and hepatic veno-occlusive disease/sinusoidal obstruction syndrome was observed in 10%. With a median follow-up of 31.5 months, the 3-year overall survival was 21.3% in the entire cohort and 37.6% among transplanted patients. Conclusion: INO represents a potent salvage option for R/R BCP-ALL. However, substantial toxicities highlight the critical need for careful patient selection and dose optimization strategies to maximize its therapeutic benefit. Trial registration: This study was registered in Clinical Research Information Service (CRIS #KCT0010009) which is connected to WHO ICTRP (Operated by Korea Centers for Disease Control and Prevention, Ministry of Health and Welfare, Republic of Korea).
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