What is the role of inotuzumab in the treatment of acute lymphoblastic leukemia (ALL)?

Updated: Oct 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In August 2017, inotuzumab was FDA approved for relapsed or refractory B-cell precursor ALL. Approval was based on findings from the phase III INO-VATE trial, which compared inotuzumab  one of the following three standard regimens: FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor) for up to four 28-day cycles, cytarabine plus mitoxantrone for up to four 15-20 day cycles, and mitoxantrone as a single agent. [79]

The risk of progression or death was reduced by 55% with inotuzumab versus standard therapy. Rates of CR or CR with incomplete hematologic recovery (CR/CRi) were 80.7% in the inotuzumab arm versus 29.4% with chemotherapy. In those who achieved a CR/CRi, 78.4% were minimal residual disease negative with inotuzumab versus 28.1% for chemotherapy. For patients who were receiving their first salvage therapy, the CR/CRi rate was 87.7% with inotuzumab versus 28.8% with chemotherapy. In the second salvage therapy setting, the CR/CRi rate with inotuzumab was 66.7% versus 30.6% with chemotherapy. [79]

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