Inotuzumab ozogamicin: Preliminary Phase I data

Preliminary data from 15 evaluable patients with relapsed or refractory CD22-positive B cell NHL who received >=1 prior treatment regimen from the dose-escalation portion of an open-label Phase I trial showed that inotuzumab ozogamicin plus rituximab, cyclophosphamide, vincristine and prednisone chemotherapy (R-CVP) led to an ORR of 87%. Specifically, 33% of patients achieved a complete response and 53% achieved a partial response. The MTD was 0.8 mg/m 2 inotuzumab ozogamicin. Treatment-related >=grade 3 adverse events included neutropenia, lymphopenia, leukopenia, thrombocytopenia and increased alanine aminotransferase (ALT) levels. Patients received rituximab, cyclophosphamide and vincristine on day 1, inotuzumab ozogamicin on day 2 and prednisone on days 1-5 of each 3-week cycle. Part 2 of the trial will evaluate the safety and tolerability of the MTD, while Part 3 of the trial will evaluate antitumor activity of the combination. Data were presented at the American Society of Hematology meeting in San Diego. ...