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

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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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Acknowledgements

This study was sponsored by Pfizer. Medical writing support was provided by Geraldine Thompson of Engage Scientific Solutions (Horsham, UK) and funded by Pfizer.

Funding

This study was sponsored by Pfizer Inc.

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Authors and Affiliations

  1. Department of Hematology, Nephrology, and Rheumatology, Graduate School of Medicine, Akita University, 1-1-1, Hondo, Akita, 010-8543, Japan

    Naohito Fujishima

  2. Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan

    Toshiki Uchida

  3. Tohoku University Hospital, Sendai, Japan

    Yasushi Onishi

  4. Samsung Medical Center, Seoul, South Korea

    Chul Won Jung

  5. Singapore General Hospital, Bukit Merah, Singapore

    Yeow Tee Goh

  6. Tokai University Hospital, Isehara, Japan

    Kiyoshi Ando

  7. Chang Gung Medical Foundation, Taipei, Taiwan

    Ming Chung Wang

  8. Pfizer Japan Inc, Tokyo, Japan

    Chiho Ono

  9. Pfizer R&D Japan G.K., Tokyo, Japan

    Miyako Matsumizu & Yosuke Fujii

  10. Pfizer Inc, Groton, CT, USA

    M. Luisa Paccagnella & Barbara Sleight

  11. Pfizer Inc, Cambridge, MA, USA

    Erik Vandendries

  12. Osaka City University, Osaka, Japan

    Masayuki Hino

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Correspondence to Naohito Fujishima.

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Conflict of interest

Naohito Fujishima: Honoraria (Pfizer). Toshiki Uchida: Honoraria (Janssen, Pfizer). Yasushi Onishi: research funding (BMS, MSD, Takeda). Chul Won Jung: no disclosures to report. Yeow Tee Goh: no disclosures to report. Kiyoshi Ando: Research funding (Celgene, Astellas, Novartis, Otsuka, Eisai, Boehringer Ingelheim, MSD, Ono, IQVIA), subsidies or donations (Novartis, Meiji Seika, Kyowa Hakko Kirin, Eisai, Takeda, Mochida). Ming Chung Wang: no disclosures to report. Chiho Ono: employment (Pfizer). Miyako Matsumizu: employment (Pfizer). M. Luisa Paccagnella: employment (Pfizer), stock ownership (Pfizer). Barbara Sleight: employment (Pfizer), stock ownership (Pfizer). Erik Vandendries: Employment (Pfizer), stock ownership (Pfizer). Yosuke Fujii: employment (Pfizer). Masayuki Hino: Honoraria (Pfizer), subsidies or donations (Pfizer, Kyowa Hakko Kirin, Chugai, Astellas, Taiho, Ono, JB).

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Fujishima, N., Uchida, T., Onishi, Y. et al. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol 110, 709–722 (2019). https://doi.org/10.1007/s12185-019-02749-0

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