Blincyto blinatumomab: Phase II data

The single-arm, international, pivotal Phase II BLAST trial in 113 evaluable precursor Beta cell ALL patients with MRD showed that once-daily 15 µg/m 2 IV Blincyto for the first 4 weeks of a 6-week cycle met the primary endpoint of rate of complete MRD response. Specifically, 78% of patients had a complete MRD response after 1 cycle of treatment (95% CI: 69%, 85%). Amgen said the lower bound of the 95% CI exceeded the 44% threshold to meet the endpoint. Additionally, 80% of patients achieved a complete MRD response across all cycles of treatment. There were 2 fatal adverse events reported -- subdural hemorrhage and pneumonitis in conjunction with influenza; the latter was deemed treatment-related. Data were presented at the American Society of Hematology meeting in San Francisco. ...