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Phase IV B1931030 study: Inotuzumab ozogamicin dose optimization in adults with R/R B-ALL
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The anti-CD22 ADC inotuzumab ozogamicin (InO) was approved by the FDA for the treatment of adult patients with R/R B-ALL in 2017 and for pediatric patients in 2024.1 The FDA subsequently issued a post-marketing requirement due to concerns that the proposed dose of 1.8 mg/m2/cycle may not provide optimal InO efficacy/safety balancing.11 The phase IV dose optimization study B1931030 (NCT03677596) therefore evaluated the risk-benefit profile of 1.2 mg/m2/cycle (run-in + randomized, n = 64) vs 1.8 mg/m2/cycle (n = 38) doses of InO in adults with R/R B-ALL who were eligible for HSCT.1 The primary objectives were to evaluate the CR/CRi, MRD-negativity, and VOD rates for the two InO dose levels.1 Results from this trial were presented at the 66th ASH Annual Meeting and Exposition by DeAngelo.1 |
| Key learnings |
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Efficacy was comparable at 1.2 mg/m2/cycle and 1.8 mg/m2/cycle doses; CR/CRi rates were 71.9% vs 68.4%, MRD-negativity was 71.7% vs 69.2%, DoR was 5.5 months vs 6.8 months, PFS rates were 5.3 months vs 6.3 months, and OS durations were 7.6 months vs 8.1 months. |
| VOD rates were higher at 1.2 mg/m2 vs 1.8 mg/m2 (12.5% vs 5.3%). The 1.8 mg/m2 dose had a higher CUI vs the 1.2 mg/m2 dose. |
| Safety was comparable between 1.2 mg/m2 and 1.8 mg/m2 doses, with Grade 3–4 AEs reported in 46.9% vs 47.4% and SAEs in 67.2% and 55.3% of patients, respectively. |
| The favorable efficacy and safety results support the use of the FDA-approved dose of 1.8 mg/m2/cycle of InO compared to a lower dose of 1.2 mg/m2/cycle in adult patients with R/R B-ALL. |
Abbreviations: ADC, antibody–drug conjugate; AE, adverse event; B-ALL, B-cell acute lymphoblastic leukemia; CR/CRi, complete remission with incomplete hematologic recovery; CUI, clinical utility index; DoR, duration of response; FDA, U.S. Food and Drug Administration; HSCT, hematopoietic stem cell transplant; InO, inotuzumab ozogamicin; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; R/R, relapsed/refractory; SAE, serious AE; VOD, veno-occlusive disease.
References
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