Phase 3 study of inotuzumab ozogamicin meets primary endpoint in adult patients with relapsed or refractory acute lymphoblastic leukemia

Pfizer has announced that the Phase 3 study investigating the treatment of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete haematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukaemia (ALL) compared to that achieved with standard of care chemotherapy.

ALL is an aggressive type of leukaemia with a poor prognosis in adults. For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.

The Phase 3 study (INO-VATE ALL) has two primary endpoints, complete haematologic remission rate and overall survival. The INO-VATE ALL Study, also known as Study 1022, is an open-label, randomised, Phase 3 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 ALL. Pfizer is continuing the study to allow for the data on overall survival to mature.

Top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option

“We are excited about the results of the INO-VATE ALL study especially since relapsed and refractory acute lymphoblastic leukaemia is a particularly difficult disease to treat in adults. The top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option for patients with relapsed or refractory disease,” said Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “We look forward to discussing these data with the FDA and other regulatory authorities.”

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.