Phase III study of Blincyto in acute lymphoblastic leukemia published in Journal of the American Medical Association.- Amgen

Amgen announced that data from a multicenter, randomized Phase III study evaluating the efficacy, safety and tolerability of Blincyto (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA). Blincyto demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with Blincyto were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with Blincyto , 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the Blincyto group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met. In the Blincyto group versus the chemotherapy group, the incidence of serious adverse events (AEs) was 24.1% vs. 43.1%, respectively, and the incidence of adverse events of grade 3 or higher was 57.4% vs. 82.4% respectively.See: "Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial." Locatelli F et al. JAMA. Published March 2, 2021. doi: 10.1001/jama.2021.0987. and "Effect of postreinduction consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial." Brown PA et al. JAMA. Published March 2, 2021. doi:10.1001/jama.2021.0669