Efficacy and Safety of Inotuzumab Ozogamicin (CMC-544) for the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma: A Systematic Review and Meta-Analysis.

Abstract

The purpose of this systematic review and meta-analysis was to evaluate the efficacy and safety of inotuzumab ozogamicin (INO) in patients with relapsed/refractory acute lymphocytic leukemia (ALL) and non-Hodgkin lymphoma (NHL). Databases (PubMed, EMBASE, and Cochrane databases) were searched through April 4, 2020. Outcome measures of efficacy covered complete remission (CR) rates and minimal residual disease response rates. Safety was evaluated by hepatic venous obstructive disease/sinus obstructive syndrome and grade ≥ 3 hematologic adverse events. We also evaluated the quality of enrolled studies by the Newcastle-Ottawa Quality Assessment Scale. A total of 12 studies involving 644 patients were included. The summary estimates of the CR and minimal residual disease response rates for patients with ALL were 67% (95% confidence interval [CI], 61%-73%) and 45% (95% CI, 37%-53%) of patients with NHL. The pooled CR rate was 28% (95% CI, 15%-47%). Thrombocytopenia and neutropenia were the most common adverse events. In patients receiving INO, venous obstructive disease/sinus obstructive syndrome, grade ≥ 3 thrombocytopenic events, grade ≥ 3 neutropenic events of the pooled estimated incidence were 8% (95% CI, 5%-14%), 29% (95% CI, 20%-39%), and 48% (95% CI, 38%-57%). According to our study, INO was effective in the treatment of relapsed/refractory ALL and NHL with limited adverse effects. High-quality randomized controlled trials and extensive follow-up are pending to confirm and update the results of this analysis in the future.

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