Pfizer has discontinued a Phase III study of its investigational cancer drug, inotuzumab ozogamicin, in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) after it failed to show benefit in overall survival. The company has notified study investigators and appropriate regulatory authorities of the decision. Investigators will work with patients in the study on an individual basis to determine an appropriate course of action.
The randomized, open-label, two-arm study (B1931008) evaluated the safety and efficacy of inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive NHL who are not candidates for intensive high-dose chemotherapy. The drug was administered once a month in combination with Roche's Rituxan (rituximab) and compared with either Teva's Treanda (bendamustine) plus rituximab , or Eli Lilly's Gemzar (gemcitabine) plus rituximab.
An independent data monitoring committee concluded during an interim analysis that treatment with inotuzumab ozogamicin plus rituximab would not meet the primary endpoint of improving overall survival when compared to the comparator arm. No new or unexpected safety issues were identified.
“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,” said Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit, in a press release. “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.”
Inotuzumab ozogamicin is an antibody-drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on about 90% of B-cell malignancies, linked to a cytotoxic agent. The molecule was developed by Pfizer and Celltech, which is now owned by UCB. Pfizer stated that it will continue evaluating inotuzumab ozogamicin in adult acute lymphoblastic leukemia (ALL). The INO-VATE ALL Study (B1931022) is an open-label, randomized, Phase III study comparing inotuzumab ozogamicin to a defined investigator’s choice of chemotherapy in patients with relapsed or refractory CD22+ ALL.