Amgen announced new data from its hematology pipeline and marketed portfolio to be presented at the 63rdAmerican Society of Hematology (ASH) Annual Meeting & Exposition in Atlanta, Georgia, and virtually, from Dec. 11-14, 2021. Amgen will present data on its bispecific T-cell engager (BiTE?) platform, including BLINCYTO? (blinatumomab), as well as KYPROLIS? (carfilzomib) and Nplate? (romiplostim). Updated data from the Phase 3 '215 trial in children with high-risk first relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) showed BLINCYTO improved event-free survival (EFS) and overall survival (OS) versus chemotherapy before allogeneic hematopoietic stem cell transplant (alloHSCT). The first presentation of safety and efficacy data with BLINCYTO administered subcutaneously in adults with relapsed or refractory B-ALL also demonstrated encouraging results. Additionally, results from the Phase 1b study investigating KYPROLIS in combination with vincristine, dexamethasone, PEG-asparaginase, daunorubicin (VXLD) induction therapy in children with relapsed or refractory ALL showing promising efficacy in highly advanced relapsed/refractory pediatric ALL will be presented in a poster discussion session. Analyses from the Pregnancy Surveillance Program (PSP) evaluating pregnancy and fetal outcomes of women exposed to Nplate highlighting no substantial safety concerns identified for mothers, fetuses and infants due to Nplate use during pregnancy will also be shared as an oral presentation on, Dec. 13, 2021. Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial evaluating event-free survival (EFS) after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell ALL. In September 2019, the BLINCYTO arm showed superior efficacy on the primary endpoint of EFS, exceeding the prespecified stopping boundary; based on the recommendation from the Independent Data Monitoring Committee (DMC), Amgen terminated enrollment. Key secondary endpoints included overall survival and MRD response, adverse events (AEs), 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA and is being conducted in Australia and various countries in the EU and Latin America. BLINCYTO is a BiTE? (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.