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<p>Inotuzumab ozogamicin (InO) was approved for the treatment of adults with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) on the basis of the phase 3 INO-VATE trial, which found that treatment-related mortality (TRM), primarily due to hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), was higher among patients who received InO versus standard therapy and proceeded to allogeneic hematopoietic stem cell transplantation (HSCT). Here, we use real-world data obtained from the Center for International Blood and Marrow Transplant Research database to evaluate post-HSCT outcomes in adult patients with ALL who received InO from 18 August2017 to 18 August 2022. Post-HSCT follow-up data were available for 244 patients with ALL (including 156 with R/R ALL) who received InO. VOD incidence within 100 days of HSCT was 14% among all patients and 18% among patients with R/R ALL. These data are consistent with a pooled analysis of the phase 1/2 study 1010 and the phase 3 INO-VATE trial that reported VOD in 19% of patients who received InO and proceeded to HSCT (<i>n</i> = 101). The current study demonstrates VOD incidence among patients receiving InO prior to HSCT in the real world is similar to that reported in clinical trials.<MediaObject ID="MOESM1"> <VideoObject FileRef="MediaObjects/11523_2025_1129_MOESM1_ESM.mp4" VideoID="1J8YMygd9z9Lrfd582sUd_"> <Caption Language="En" xml:lang="en"> <CaptionContent> <p>Supplementary file1 (MP4 165809 KB)</p> </CaptionContent> </Caption> </VideoObject> </MediaObject></p>

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CIBMTR Registry Data on Inotuzumab Ozogamicin Treatment in Patients with ALL Who Proceeded to Hematopoietic Stem Cell Transplant—A Podcast

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年3月20日

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  • Marcos de Lima,
  • David I. Marks

摘要

Inotuzumab ozogamicin (InO) was approved for the treatment of adults with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) on the basis of the phase 3 INO-VATE trial, which found that treatment-related mortality (TRM), primarily due to hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), was higher among patients who received InO versus standard therapy and proceeded to allogeneic hematopoietic stem cell transplantation (HSCT). Here, we use real-world data obtained from the Center for International Blood and Marrow Transplant Research database to evaluate post-HSCT outcomes in adult patients with ALL who received InO from 18 August2017 to 18 August 2022. Post-HSCT follow-up data were available for 244 patients with ALL (including 156 with R/R ALL) who received InO. VOD incidence within 100 days of HSCT was 14% among all patients and 18% among patients with R/R ALL. These data are consistent with a pooled analysis of the phase 1/2 study 1010 and the phase 3 INO-VATE trial that reported VOD in 19% of patients who received InO and proceeded to HSCT (n = 101). The current study demonstrates VOD incidence among patients receiving InO prior to HSCT in the real world is similar to that reported in clinical trials.

Supplementary file1 (MP4 165809 KB)