Pfizer has announced that its phase III study of inotuzumab ozogamicin, an investigational antibody-drug conjugate, met its primary endpoint of a higher complete hematologic remission rate than standard therapy in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL).
The INO-VATE ALL Study is an open-label, randomized study evaluating the safety and efficacy of inotuzumab ozogamicin, compared with standard chemotherapy in adult patients with ALL. The two primary endpoints are hematologic remission (as defined by a complete response with or without platelet and/or neutrophil recovery) and overall survival. Pfizer said that the study will continue in order to allow the data on overall survival to mature.
Inotuzumab ozogamicin was administered intravenously once weekly for 3 weeks for a 3- to 4-week cycle up to six cycles. There were 326 patients enrolled in the trial.
