NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) Monday said it has discontinued its Phase 3 study of inotuzumab ozogamicin in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy.
During a interim analysis, an independent data monitoring committee concluded that the study would not meet the primary objective of improving overall survival when compared to the comparator arm.
In the randomized, open-label, two-arm study inotuzumab ozogamicin was administered on a once-a-month schedule in combination with rituximab and compared with an active comparator arm.
'Hematologic cancers are a complex group of diseases, with more than 70 different types of lymphomas, leukemias or myelomas that require unique treatment options. We remain committed to evaluating inotuzumab ozogamicin in patients with hematologic malignancies.' said Dr. Mace Rothenberg, SVP, Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit.
Pfizer has notified the study investigators and appropriate regulatory authorities of the decision to discontinue the study. Investigators will work with patients in the study on an individual basis to determine an appropriate course of action.
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