Amgen's Blincyto shows improved survival in leukemia patients in Phase 3 trial
Amgen announced the New England Journal of Medicine published results from the Phase 3 TOWER study evaluating the efficacy of Blincyto versus standard of care chemotherapy in high-risk adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, one of the most aggressive B-cell malignancies. Results showed median overall survival was 7.7 months for Blincyto versus four months for SOC. The TOWER study is the confirmatory study for the Phase 2 trial that supported the FDA's accelerated approval designation for Blincyto in 2014. The survival benefit for Blincyto was independent of allogeneic stem cell transplant. Improvement in OS was generally consistent regardless of age, prior salvage therapy or prior alloSCT. Remission rates were also higher for Blincyto, 34% of complete remission, versus 16% in the SOC group. Among patients with complete remission or complete remission with partial or incomplete hematologic recovery, 76% in the Blincyto group versus 48% in the SOC group achieved minimal residual disease negative status. Safety results among subjects who received Blincyto were comparable to those seen in the Phase 2 studies in adult patients with Ph- relapsed or refractory B-cell precursor ALL.