International Journal of Hematology

DOI: 10.1007/s12185-019-02749-0 Pages: 709-722

Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia

1. Akita University, Department of Hematology, Nephrology, and Rheumatology, Graduate School of Medicine

2. Japanese Red Cross Nagoya Daini Hospital

3. Tohoku University Hospital

4. Samsung Medical Center

5. Singapore General Hospital

6. Tokai University Hospital

7. Chang Gung Medical Foundation

8. Pfizer Japan Inc

9. Pfizer R&D Japan G.K.

10. Pfizer Inc

11. Pfizer Inc

12. Osaka City University

Correspondence to:
Naohito Fujishima
Tel: 018-884-6313
Email: naofuji@doc.med.akita-u.ac.jp

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Abstract

Inotuzumab ozogamicin (InO) is a targeted treatment for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). InO was previously studied in INO-VATE, an international, open-label, randomized phase 3 trial comparing InO against standard of care (SoC). In the present subgroup analysis, we evaluated outcomes in the 55 Asian patients who were randomized in INO-VATE (31 InO and 24 SoC). Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 22/31 patients treated with InO versus 5/24 treated with SoC. In the InO arm, more of the patients achieving CR/CRi were minimal residual disease (MRD)-negative (17/22 versus 1/5), and more patients proceeded directly to hematopoietic stem cell transplantation (15/31 versus 3/24). Median overall survival for the respective arms was 5.8 versus 3.9 months (hazard ratio 0.67; 97.5% CI 0.28, 1.62). In the safety analysis (n = 51), the most common adverse events were hematologic. Sinusoidal obstruction syndrome was reported in five InO patients and one SoC patient. In conclusion, Asian patients with relapsed or refractory B-cell ALL experienced improved efficacy with InO versus SoC, with an efficacy and safety profile consistent with results of the overall INO-VATE population.

Clinical trial registration: ClinicalTrials.gov identifier: NCT01564784.

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