Inotuzumab ozogamicin: Phase II data

An open-label Phase II trial in 54 evaluable patients with relapsed or refractory CD20- or CD22-positive DLBCL showed that 1.8 mg/m 2 IV inotuzumab ozogamicin every 21 days plus rituximab for up to 6 cycles led to an ORR of 35%. Specifically, 24% of patients achieved a complete response and 11% achieved a partial response, plus 13% of patients achieved stable disease. Additionally, inotuzumab ozogamicin plus rituximab led to 6- and 12-month PFS rates of 31% and 13%, respectively, with a median OS of 10 months. In 18 responders who received high-dose chemotherapy followed by ASCT, the combination led to 6- and 12-month PFS rates of 79% and 35%, respectively, while median OS has not yet been reached. The most common adverse events were thrombocytopenia, nausea, lymphopenia, increased aspartate aminotransferase (AST) levels, fatigue, neutropenia, pyrexia and vomiting. Data were presented at the American Society of Hematology meeting in San Diego. ...