Multicenter phase 2 trial of inotuzumab ozogamicin induction therapy for Ph-negative B-ALL in patients older than 55 years

Despite recent advances in adapting the intensity of treatment for older patients with ALL, current protocols are associated with high rates of early death, treatment-related toxicity, and dismal prognosis. The open-label, multicenter phase 2 INITIAL-1 trial in Germany evaluated inotuzumab ozogamicin and dexamethasone as induction therapy in patients older than 55 years with newly diagnosed, CD22-positive, Ph-negative B-ALL. Patients received up to three cycles of inotuzumab ozogamicine/dexamethasone induction therapy and up to seix cycles age-adapted consolidation and maintenance therapy. This treatment was well tolerated and resulted in high rates of remission and overall survival. The authors conclude that these data provide a rationale for integrating inotuzumab ozogamicin into first-line regimens for older patients with B-ALL.