Success for inotuzumab ozogamicin in Phase III INO-VATE ALL study in ALL- Pfizer
Pfizer announced 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. Pfizer is continuing the study to allow for the data on overall survival to mature.
No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting. The INO-VATE ALL Study, also known as Study 1022, is an open-label, randomized, Phase III study evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin as compared with a defined set of chemotherapy choices in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL). The two primary endpoints are hematologic remission, defined as a complete response with or without platelet and/or neutrophil recovery (CR/CRi), and overall survival.
Comment: Inotuzumab ozogamicin failed a Phase III study for CD-22 positive non hodgkins lymphoma as the drug plus rituximab did not improve overall survival. Development in this condition has stopped.
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