Phase III TOWER study shows Blincyto (blinatumomab) offers two-fold improvement in overall survival in PH- B-cell precursor acute lymphoblastic leukemia- Amgen

Amgen announced new data from a prespecified interim analysis of the Phase III TOWER study, in which Blincyto (blinatumomab) demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study evaluated the efficacy of Blincyto versus SOC chemotherapy in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Results from the analysis showed that median OS was 7.7 months for Blincyto versus 4 months for SOC. As per the recommendation of an independent data monitoring committee, Amgen ended the study early for efficacy based on these results. Improvement in OS was consistent across subgroups regardless of age, prior salvage therapy or prior allogeneic stem cell transplant (alloSCT). Serious adverse events included infection, blood and lymphatic system disorders, nervous system disorders and cytokine release syndrome. The Blincyto adverse events observed in the TOWER study were consistent with the known safety profile of Blincyto. The data will be presented during The Presidential Symposium at the 21st Congress of the European Hematology Association meeting.

Comment: The TOWER study is the confirmatory trial for Blincyto, and Amgen plans to file for full approval of Blincyto based on results from the study.