21 May 2013 - Healthcare company Pfizer Inc (NYSE:PFE) announced on Monday the discontinuation of a Phase 3 randomised, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who are not candidates for intensive high-dose chemotherapy.

In this study, inotuzumab ozogamicin was administered on a once-a-month schedule in combination with rituximab and compared with an active comparator arm (investigator's choice of bendamustine plus rituximab or gemcitabine plus rituximab). During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) concluded that in this study treatment with inotuzumab ozogamicin plus rituximab would not meet the primary objective of improving overall survival (OS) when compared to the comparator arm, Pfizer said.

As a result, the company decided to discontinue the study.

Pfizer said that it 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.

Also, Pfizer will continue to evaluate inotuzumab ozogamicin in other haematological malignancies.