Epratuzumab: Phase II data

The international Phase II COG-ADVL04P2 trial in 116 patients aged 2-30 with early bone marrow relapse of B cell precursor ALL showed that chemotherapy plus epratuzumab missed the primary endpoint of a >=13% improvement in the rate of second complete remission compared to a 67% rate of second complete remission for historical controls receiving chemotherapy alone. Specifically, chemotherapy plus epratuzumab given weekly for 4 weeks and twice-weekly for 8 weeks led to rates of second complete remission of 65% and 66%, respectively. However, epratuzumab-treated patients who achieved a second complete remission were significantly more likely to become minimal residual disease negative compared to patients not treated with epratuzumab. The trial was sponsored by the Children's Oncology Group. Data were presented at the American Society of Hematology meeting in San Diego. ...