The company will continue evaluating the compound in other hematologic malignancies such as adult acute lymphoblastic leukemia (ALL).
Pfizer’s oncology business unit clinical development and medical affairs senior vice president Dr. Mace Rothenberg said work to understand the findings from the review is going on to determine the presence of patterns of outcome that may help gain greater understanding of the potential effect of inotuzumab ozogamicin in specific patient subsets within the heterogeneous patient population enrolled in the trial.
"Hematologic cancers are a complex group of diseases, with more than 70 different types of lymphomas, leukemias or myelomas that require unique treatment options," Rothenberg added.
The open-label (B1931008) was designed to assess the safety and efficacy of the investigational compound in patients with relapsed or refractory CD22+ aggressive NHL who are not candidates for intensive high-dose chemotherapy.
The two-arm study administered inotuzumab ozogamicin on a once-a-month schedule in combination with rituximab and compared with an active comparator arm.
An independent Data Monitoring Committee concluded that the study would not meet the primary objective of improving overall survival (OS) when compared to the comparator arm though no new or unexpected safety issues were identified.