Pfizer announced the discontinuation of a Phase III study of inotuzumab ozogamicin in patients with non-Hodgkin's lymphoma (NHL) after a planned interim analysis indicated that the experimental drug would not improve overall survival. "We are working to better understand the findings," remarked Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit.
The trial randomised patients with relapsed or refractory CD22+ aggressive NHL who are not candidates for intensive high-dose chemotherapy to receive inotuzumab ozogamicin in combination with Roche's Rituxan (rituximab) or a combination of Rituxan and either Teva's Treanda (bendamustine) or gemcitabine. Pfizer noted that the analysis by the independent data monitoring committee didn't identify any new or unexpected safety issues.
The antibody-drug conjugate inotuzumab ozogamicin combines a monoclonal antibody targeting the cell surface antigen CD22 linked to a cytotoxic agent. Pfizer said that the late-stage INO-VATE ALL Study of the drug in adults with acute lymphoblastic leukaemia will continue. Cowen & Co analysts had forecast sales of $100 million in 2016 for the therapy if approved.
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