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InO in R/R B-ALL across BMI subgroups: A pooled analysis of three phase I–IV studies
Results from a post hoc pooled analysis of the phase I/II B1931010 (NCT01363297), phase III INO-VATE (NCT01564784), and phase IV B1931030 (NCT03677596) studies, evaluating inotuzumab ozogamicin (InO) across different body mass index (BMI) subgroups in 338 adults with relapsed/refractory (R/R) CD22+ B-cell acute lymphoblastic leukemia (B-ALL) were published in Targeted Oncology by Stock et al. Subgroups included patients with a BMI <25 kg/m2 (normal; n = 155), 25–30 kg/m2 (overweight; n = 116), and >30 kg/m2 (obese; n = 67).
Key data: Complete remission (CR) or CR with incomplete count recovery (CRi) was observed in 69.7%, 75.9%, 68.7%, and 84.6% of patients in the <25, 25–30, >30, and >40 kg/m² BMI subgroups, respectively. The 24-month progression-free survival (PFS) rates were 19.9%, 12.8%, 10.9%, and 23.1%, while the 24-month overall survival (OS) rates were 28.1%, 22.1%, 17.5%, and 23.1% in the <25, 25–30, >30, and >40 kg/m² BMI subgroups, respectively. Treatment-emergent adverse events (TEAEs) occurred in 98.1%, 96.6%, and 98.5% of patients in the <25, 25–30, and >30 kg/m² BMI subgroups, respectively. The most common Grade ≥3 TEAEs were similar across BMI groups and included neutropenia (36.1%), thrombocytopenia (34.9%), febrile neutropenia (23.7%), anemia (18.9%), leukopenia (17.2%), lymphopenia (8.3%), sinusoidal obstruction syndrome (SOS; 8.3%), increased gamma-glutamyl transferase (5.9%), and pneumonia (5.6%)
Key learning: In this post hoc analysis, efficacy and safety outcomes were broadly consistent across BMI subgroups in adults with R/R CD22+ B-ALL, supporting the use of InO without dose-capping in this population.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
