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Study of Lymphoma Drug Halted
The plug has been pulled on a phase III randomized, open-label trial that was evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin (Pfizer) in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who were not candidates for intensive high-dose chemotherapy.
In the study, inotuzumab ozogamicin was administered on a once-a-month schedule in combination with rituximab and was compared with an active comparator arm (the investigator’s choice of bendamustine plus rituximab or gemcitabine plus rituximab). During a scheduled interim analysis, an independent data monitoring committee concluded that treatment with inotuzumab ozogamicin plus rituximab would not meet the primary objective of improving overall survival when compared with the comparator arm.
Inotuzumab ozogamicin is an investigational antibody–drug conjugate (ADC) consisting of a monoclonal antibody that targets CD22 — a cell-surface antigen expressed on approximately 90% of B-cell malignancies — linked to a cytotoxic agent, calicheamicin. When the drug binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the calicheamicin is released to destroy the cell.
Inotuzumab ozogamicin, administered on a weekly basis, 3 weeks out of 4, continues to be evaluated in adults with acute lymphoblastic leukemia (ALL). The INO-VATE ALL trial is an open-label, randomized, phase III study of inotuzumab ozogamicin compared with a defined investigator’s choice of chemotherapy in adult patients with relapsed or refractory CD22+ ALL.
Source: Pfizer; May 20, 2013.