Amgen has presented Blincyto’s (blinatumomab) top-line results of Phase II trial in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukaemia (ALL).
According to the firm, the investigational, open-label, single-arm, and multi-centre study demonstrated blinatumomab monotherapy induced a complete remission or complete remission with partial haematological recovery within two cycles of treatment in a clinically meaningful number of patients.
Blincyto is claimed to be the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct product and first single-agent immunotherapy that was approved by the US Food and Drug Administration (FDA) to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.
Bispecific T cell engager (BiTE) constructs are a type of immunotherapy being investigated to combat cancer by helping the body’s immune system to detect and target malignant cells.
Amgen research and development executive vice-president Dr Sean Harper said: "These top-line results are encouraging and support blinatumomab as a potential treatment option for patients with relapsed or refractory Philadelphia chromosome-positive B-cell precursor ALL.
"We are hopeful that our comprehensive ALL development programme for blinatumomab, the first clinical and regulatory validation of the BiTE platform, will continue to demonstrate clinical effectiveness for patients with this serious disease."
The trial, which enrolled adult subjects with relapsed or refractory Ph+ B-cell precursor ALL, comprised of screening period, induction treatment period, consolidation treatment period and safety follow-up visit 30 days after treatment.
Subjects have been followed for response duration and survival every three months or death, whichever occurred first, following the safety follow-up visit.
Image: Bone marrow smear from a patient with acute lymphoblastic leukaemia. Photo: courtesy of Furfur.