Amgen: JCO publishes 'positive' results from study of BLINCYTO
Amgen announced that the Journal of Clinical Oncology published results from the Phase 1/2 '205 single-arm trial evaluating BLINCYTO in pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Based on data from an exploratory pooled analysis of 70 patients who received the recommended dose of BLINCYTO in the Phase 1 or Phase 2 portions of the study, 27 patients (39%, 95% confidence interval, 27%-51%) achieved complete remission within the first two cycles. The most frequent grade greater than or equal to 3 adverse events among the patients who received the recommended dose were anemia (36%), thrombocytopenia (21%), febrile neutropenia (17%), hypokalemia (17%) and neutropenia (17%). The most common AEs overall were pyrexia (80%), anemia (41%), nausea (33%) and headache (30%).