Background: Adults with relapsed or refractory B-precursor acute lymphoblastic leukaemia have an unfavourable prognosis. Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19, an antigen consistently expressed on B-lineage acute lymphoblastic leukaemia cells. We aimed to confirm the activity and safety profile of blinatumomab for acute lymphoblastic leukaemia. Methods: In a multicentre, single-arm, open-label phase 2 study, we enrolled adult patients with Philadelphia-chromosome-negative, primary refractory or relapsed first relapse within 12 months of first remission, relapse within 12 months after allogeneic haemopoietic stem-cell transplantation [HSCT], or no response to or relapse after first salvage therapy or beyond leukaemia.
The primary endpoint was complete remission CR or CR with partial haematological recovery of peripheral blood counts CRh within the first two cycles. Analysis was by intention to treat. This trial is registered at ClinicalTrials. Findings: Between Jan 13, , and Oct 10, , patients were enrolled and treated with blinatumomab. Three deaths due to sepsis, Escherichia coli sepsis, and Candida infection were thought to be treatment-related by the investigators.
Interpretation: Single-agent blinatumomab showed antileukaemia activity in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia characterised by negative prognostic factors. Further assessment of blinatumomab treatment earlier in the course of the disease and in combination with other treatment approaches is warranted.
Funding: Amgen. Abstract Background: Adults with relapsed or refractory B-precursor acute lymphoblastic leukaemia have an unfavourable prognosis.
Substances Antibodies, Bispecific Antineoplastic Agents blinatumomab. Associated data ClinicalTrials.
