Blinatumomab: Phase II data

A single-arm, open-label, international Phase II trial in 189 patients with precursor B cell relapsed or refractory ALL showed that blinatumomab by continuous IV infusion for 28 days followed by 14 days off therapy for up to 5 cycles led to a CR/CRh* rate, the primary endpoint, of 43%, with 80% of responses occurring within the first treatment cycle. The CR rate was 34% and the CRh* rate was 10%. Median relapse-free survival was 5.9 months and median OS was 6.1 months. The most common adverse events were pyrexia, headache and febrile neutropenia. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...