Bad news for non-Hodgkin's lymphoma (NHL) sufferers: Pfizer is discontinuing a Phase III randomized, open-label, two-arm study (B1931008) evaluating the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive NHL who are not candidates for intensive high-dose chemotherapy. Apparently, the drug just isn't working as well as they hoped it would in this situation.
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. Thankfully, 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, M.D., svp, clinical development and medical affairs for Pfizer’s oncology business unit. “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.”
All is not lost for the drug, however: Inotuzumab ozogamicin, administered on a weekly basis three weeks out of four, is still being evaluated for 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.