Pfizer's inotuzumab ozogamicin meets endpoint in Phase III ALL study
US pharma giant Pfizer (NYSE: PFE) says that the Phase III study investigating the treatment of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard of care chemotherapy.
The Phase III study has two primary endpoints, complete hematologic remission rate and overall survival. Pfizer is continuing the study to allow for the data on overall survival to mature.
A couple of years ago, discontinued a Phase III randomized, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational drug inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who are not candidates for intensive high-dose chemotherapy due to disappointing results. (The Pharma Letter May 21, 2013).
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