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

Naohito Fujishima, Toshiki Uchida, Yasushi Onishi, Chul Won Jung, Yeow Tee Goh, Kiyoshi Ando, Ming Chung Wang, Chiho Ono, Miyako Matsumizu, M. Luisa Paccagnella, Barbara Sleight, Erik Vandendries, Yosuke Fujii, Masayuki Hino

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)709-722
Number of pages14
JournalInternational journal of hematology
Volume110
Issue number6
DOIs
Publication statusPublished - 2019 Dec 1

Keywords

  • Acute lymphoblastic leukemia
  • Asian
  • Inotuzumab ozogamicin
  • Relapsed/refractory

ASJC Scopus subject areas

  • Hematology

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