New Protocol: Inotuzumab Ozogamicin Then Blinatumomab for Older Adults with Ph-Negative ALL

Inotuzumab ozogamicin followed by blinatumomab without chemotherapy showed high remission and survival rates in older patients with Ph-negative B-cell ALL. The regimen achieved a CR by the end of blinatumomab in 97% of patients and a 12-month event-free survival of 75%, representing a significant improvement over historical outcomes with conventional therapies.

  • Study

    Phase II study [Alliance A041703]
    Older patients with untreated Ph-negative, CD22-positive B-cell ALL
    Inotuzumab ozogamicin x 2 (n=33) followed by blinatumomab x 4-5



  • Efficacy

    CR: 85% after inotuzumab ozogamicin, 97% by end of blinatumomab
    1-yr EFS: 75% (HR 0.28)
    12-mo OS: 85%



  • Safety

    Grade >=3 AEs: Cytopenias, Febrile neutropenia
    Encephalopathy: 9% with blinatumomab
    One induction death due to respiratory failure and liver complications


  • J Clin Oncol 2025;43:3526-3535

    Wieduwilt MJ, Yin J, Kour O New Protocol: Inotuzumab Ozogamicin Then Blinatumomab for Older Adults with Ph-Negative ALL

    http://doi.org/10.1200/JCO-25-00307

    Reviewed by Ulas D. Bayraktar, MD on Nov 15, 2025

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