Inotuzumab ozogamycyny w leczeniu chorych na ostrą białaczkę limfoblastyczną

Abstract

Acute lymphoblastic leukemia (ALL) comprises about 20% of leukemias in adult. Though the high complete remission (CR) rates after the first-line chemotherapy, only 30–40% of ALL patients may be cured. The prognosis of relapsed/refractory ALL remains poor. The 5-year overall survival (OS) rate is 7–10%. In recent years, new therapies utilizing monoclonal antibodies have been investigated. Inotuzumab ozogamycin is a humanized anti-CD22 antibody conjugated to an alkylating agent — calicheamicin. The drug was registered for relapsed/refractory ALL in adults based on INO-VATE trial, a phase III trial comparing efficacy of inotuzumab ozogamycin to chemotherapy. CR rates, progression-free survival, and OS were significantly higher in the inotuzumab group. In addition, significantly more patients from the inotuzumab group were treated with allogeneic hematopoietic stem cell transplantation (allo-HSCT). The most common adverse events were neutropenia and thrombocytopenia. Among the non-hematological adverse events the veno-occlusive disease (VOD) was the most dangerous. The frequency of VOD increased in patients who underwent allo-HSCT. This article presents the most important clinical trials with inotuzumab ozogamycin and the toxicity of the drug.