Outcomes by Body Mass Index in Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin.

Authors

Wendy Stock, Ryan D Cassaday, Daniel J DeAngelo, Anjali Advani, Nicola Gokbuget, Josep Ribera, Wei Jiang, Susana Pulido, Erik Vandendries, Nathan Braniff, Elias Jabbour, Hagop Kantarjian

Published in

Targeted oncology. Sep 16, 2026. Epub Sep 16, 2026.

Abstract

Inotuzumab ozogamicin (lnO) is approved for the treatment of adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Elevated body mass index (BMI) could be associated with worse outcomes.
To conduct post hoc BMI-stratified efficacy/safety analyses of lnO.
Pooled data from phase 1-4 InO trials were analyzed, with patients grouped by BMI: < 25 kg/m² (normal), 25-30 kg/m² (overweight), and > 30 kg/m² (obese), including a subset of morbidly obese (> 40 kg/m²) patients. Descriptive analyses included efficacy, safety, and pharmacokinetic simulations for InO.
Across 338 patients, complete remission (CR) or CR with incomplete count recovery (CRi) was achieved in 69.7%, 75.9%, 68.7%, and 84.6% patients in the < 25, 25-30, > 30, and > 40 kg/m² subgroups, respectively. The 24-month probability of progression-free survival was 19.9%, 12.8%, 10.9%, and 23.1%; the 24-month overall survival probability was 28.1%, 22.1%, 17.5%, and 23.1% in these subgroups, respectively. Most deaths were due to progressive disease. Most patients experienced treatment-emergent adverse events (TEAEs), with similar incidence across subgroups. The most common grade ≥ 3 TEAE was neutropenia (36.1%), with sinusoidal obstruction syndrome (SOS) observed in 8.3%. 143 patients (42%) proceeded to hematopoietic stem cell transplant (HSCT) after lnO treatment, with 31 (21.7%) experiencing post-HSCT SOS; the BMI > 40 kg/m² subgroup (n = 7 receiving HSCT) had the numerically highest post-HSCT non-relapse mortality. In simulations for dose capping (capped maximum dose), exposure metrics were similar across subgroups with/without dose capping.
Efficacy/safety outcomes with InO were consistent across BMI subgroups. Dose-capping does not appear to be required.

PMID:
42747695
Bibliographic data and abstract were imported from PubMed on 17 Sep 2026.

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