June 12, 2016
Pfizer Inc. has announced the publication of findings from the Phase 3 INO-VATE ALL study in The New England Journal of Medicine’s online issue. This study, also known as Study 1022, is a randomized, open-label, Phase 3 study evaluating the efficacy and safety of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with refractory or relapsed CD22-positive acute lymphoblastic leukemia (ALL). Results of the study showed improvement over chemotherapy on a number of measures including progression-free survival (PFS) and complete hematologic remission.
“Relapsed or refractory ALL is an aggressive leukemia in urgent need of new treatment options as about half of adult patients will not respond to chemotherapy or will see their disease return. The efficacy results seen in patients treated with inotuzumab ozogamicin in this study are impressive, particularly median progression-free survival, high rates of hematological remission and absence of minimal residual disease. These results suggest inotuzumab ozogamicin, if approved, could be a valuable new addition to currently available treatment options for ALL patients, including as a bridge to stem cell transplantation, which is the best chance for a cure at this stage of the disease,” said Hagop M. Kantarjian, M. D., lead study investigator and professor, The University of Texas MD Anderson Cancer Center.
As said by Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development: “Adult patients with relapsed or refractory ALL have a five-year survival rate of less than 10 percent, making these patients particularly difficult to treat. To see remission rates and two-year survival rates that are more than doubled compared to standard of care chemotherapy is very gratifying. We believe these data add to the growing body of evidence that supports inotuzumab ozogamicin as an important potential treatment option in adults with relapsed or refractory ALL.”