Amgen (AMGN) Receives European Commission Approval To Add Overall Survival Data To BLINCYTO®

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Amgen Receives European Commission Approval To Add Overall Survival Data To BLINCYTO® (blinatumomab) Label

Amgen (AMGN) today announced that the European Commission (EC) has granted a full marketing authorization for BLINCYTO® (blinatumomab) based on the overall survival (OS) data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

“BLINCYTO is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care,” said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. “For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces BLINCYTO as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer.”

BLINCYTO is the first-and-only bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy construct approved globally. It is also the first bispecific immunotherapy from Amgen’s BiTE® platform, an innovative approach that helps the body’s immune system target cancer cells.

In the TOWER study, BLINCYTO demonstrated a superior improvement in median OS over standard of care (SOC) chemotherapy. Median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO versus four months (95 percent CI: 2.9, 5.3) for SOC (HR for death=0.71; p=0.012). For patients treated in first salvage, the median OS was 11.1 months for BLINCYTO versus 5.3 months for SOC (HR=0.6, 95 percent CI: 0.39, 0.91). Safety results among subjects who received BLINCYTO were comparable to those seen in the previous Phase 2 studies of BLINCYTO in adult patients with Ph- relapsed or refractory B-cell precursor ALL.

Approval via the centralized procedure allows for obtaining a marketing authorization from the EC, which is valid in all European Union (EU) and European Economic Area (EEA)-European Free Trade Association (EFTA) states (NorwayIceland and Liechtenstein).

About TOWER
The TOWER study was a Phase 3, randomized, active-controlled, open-label study investigating the efficacy of BLINCYTO versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL. The study enrolled a difficult-to-treat patient population which included patients at several states of relapse. In the BLINCYTO arm, this included 35 percent of patients that had relapsed post-allogenic hematopoietic stem cell transplant (alloHSCT), and excluded those with late first relapse (≥12 months after initial remission). Patients were randomized in a 2:1 ratio to receive BLINCYTO (n=271) or treatment with investigator choice of SOC chemotherapy (n=134). The determination of efficacy was based on OS. Per the recommendation of an independent data monitoring committee, Amgen ended the study early for evidence of superior efficacy in the BLINCYTO arm versus SOC chemotherapy. These results were published in The New England Journal of Medicine.

About Adult ALL in Europe
ALL is a rare and rapidly progressing cancer of the blood and bone marrow.1,2 The incidence of adult ALL in European countries is generally between 0.6 to 0.9 per 100,000 persons per year.3 In adult ALL, approximately 75 percent is B-cell precursor ALL, of which 75-80 percent is Ph- and roughly half will be refractory to treatment or experience relapse.Thus, with a population projection of 416 million adults in the EU,4 it is estimated that the incidence of adult Ph- relapsed or refractory B-cell precursor ALL in the EU is approximately 900 patients per year.5

About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the FDA in 2014, and carries full approval in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival (RFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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