Inotuzumab ozogamicin (Pfizer) fails Phase III trial for NHL
Pfizer Inc. announced the discontinuation of a Phase III randomized, 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 when compared to the comparator arm. No new or unexpected safety issues were identified.
Inotuzumab ozogamicin, administered on a weekly basis, 3 weeks out of 4, continues to be evaluated in adult acute lymphoblastic leukemia (ALL).
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