The FINANCIAL — Amgen on July 16 announced the top-line results of a Phase 2 open-label, single-arm, multicenter trial to evaluate the efficacy and safety of BLINCYTO (blinatumomab) in adults with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL).
The investigational study 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. Overall safety results from this study were consistent with the known blinatumomab safety profile, according to Amgen.
The data will be submitted to a future medical conference and for publication.
“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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”
Philadelphia chromosome-positive B-cell precursor ALL
Approximately one-fourth of adult ALL expresses the oncogenic protein BCR-ABL1 that results from the t (9;22) chromosome translocation known as the Philadelphia chromosome.
Trial Design (NCT02000427)
This study enrolled adult subjects with relapsed or refractory Ph+ B-cell precursor ALL. This was an open-label, single-arm, multicenter study consisting of a screening period, an induction treatment period (two cycles of blinatumomab), a consolidation treatment period (up to three additional cycles of blinatumomab for applicable subjects), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, subjects were followed for response duration and survival every 3 months for 18 months or death, whichever occurred first.