Amgen reports Phase II trial results of Blincyto in patients with Ph+ B-cell precursor ALL

The open-label, single-arm, multicenter trial showed blinatumomab monotherapy induced a complete remission or complete remission with partial hematological recovery within two cycles of treatment in a clinically meaningful number of patients.

The company said that overall safety results from this trial were consistent with the known blinatumomab safety profile.

Amgen Research and Development executive vice-president 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 program 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 adults with relapsed or refractory Ph+ B-cell precursor ALL, involved a screening period, an induction treatment period, a consolidation treatment period, and a safety follow-up visit 30 days after treatment.

After the safety follow-up visit, these patients were followed for response duration and survival every three months for 18 months or death, whichever occurred first.

Blincyto is the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct product, and the first single-agent immunotherapy to be approved by the FDA to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.