CIBMTR Registry Data on Inotuzumab Ozogamicin Treatment in Patients with ALL Who Proceeded to Hematopoietic Stem Cell...

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).