The Phase 2 study was an open-label, single-arm multicenter trial evaluating the efficacy and safety in adults with relapsed or refractory Ph+ B-cell precursor ALL. It consisted of a screening period, an induction treatment period (two cycles), a consolidation treatment period (up to three additional cycles), and a safety follow-up visit 30 days after treatment. Patients were also followed up for response duration and survival every three months for 18 months or death, whichever occurred first. Treatment with Blincyto showed complete remission with or without partial hematological recovery after two cycles of treatment in a clinically significant number of patients.
Blincyto is already approved for relapsed or refractory Ph- B-cell precursor ALL. It is the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct product, which works by triggering apoptosis in cancer cells. Prior to its approval, the Food and Drug Administration (FDA) granted Blincyto priority review for its breakthrough technology.
For more information, call (800) 772-6436 or visit Blincyto.com.