Updated on 22 May 2013
Pfizer stops its phase III study of Inotuzumab Ozogamicin
Singapore: Pfizer has discontinued its 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 of bendamustine plus rituximab or gemcitabine plus rituximab. During a scheduled interim analysis, an independent data monitoring committee (DMC) concluded that in the study treatment with inotuzumab ozogamicin plus rituximab would not meet the primary objective of improving overall survival (OS) when compared to the comparator arm. No new or unexpected safety issues were identified.
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.
Inotuzumab Ozogamicin, administered on a weekly basis, three weeks out of four, continues to be evaluated in adult acute lymphoblastic leukemia (ALL). The Ino-Vate ALL Study (B1931022) is an open-label, randomized, phase III study of inotuzumab ozogamicin compared to a defined investigator's choice of chemotherapy in adult patients with relapsed or refractory CD22+ ALL.
Dr Mace Rothenberg, senior vice president, clinical development and medical affairs, oncology business unit, Pfizer, said that, "We are working to better understand the findings from this review to determine if there are any patterns of outcome that may help us gain greater understanding of the potential effect of inotuzumab ozogamicin in specific patient subsets within the heterogeneous patient population enrolled in this trial."