Inotuzumab Ozogamicin: A Review in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia.

The intravenous CD22-directed antibody drug conjugate inotuzumab ozogamicin (Besponsa®) is approved in several countries including in the USA, EU and Japan, as monotherapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL). In adults with relapsed/refractory B-cell ALL who had received one or two prior treatment regimens, inotuzumab ozogamicin was associated with significantly higher rates of complete remission (including complete remission with incomplete haematological recovery) [CR/CRi] than standard therapy in the pivotal INO-VATE ALL trial. Inotuzumab ozogamicin was associated with significantly longer progression-free survival (PFS), duration of remission and higher haematopoietic stem cell transplantation (HSCT) rates than standard therapy. Although there was no significant between-group difference in overall survival duration as per the study design, the 2-year survival probability in the inotuzumab ozogamicin arm was twice that in the control arm. Inotuzumab ozogamicin had an acceptable tolerability profile. Thus, inotuzumab ozogamicin is an important new treatment option for patients with relapsed/refractory CD22-positive B-cell ALL.