Pfizer discontinues Phase III of inotuzumab for NHL
Pfizer Inc. (NYSE:PFE) said it discontinued the Phase III B1931008 trial evaluating inotuzumab ozogamicin to treat relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma. The move came after an interim analysis by an independent DMC showed once-monthly inotuzumab ozogamicin plus rituximab would not meet the primary endpoint of improving overall survival (OS) vs. investigator's choice of rituximab plus either bendamustine or gemcitabine. The open-label trial was slated to enroll about 377 patients who are not candidates for intensive high-dose chemotherapy.
Pfizer said it will review the data to determine if there are subsets of patients that benefited from treatment with inotuzumab ozogamicin, a humanized mAb against CD22 linked to the calicheamicin cytotoxin. The pharma said it will also continue to evaluate the product in the Phase III INO-VATE ALL (B1931022) trial to treat adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL). Pfizer, which announced the news late Monday, is co-developing inotuzumab ozogamicin with UCB Group (Euronext:UCB), which was up EUR 0.11 to EUR 44.56 on the day. ...