Amgen Inc. ($AMGN) reported the results of the Phase 3 study of its leukemia drug Blincyto (blinatumomab). The company said that the drug almost doubled the overall survival (OS) rate in high-risk patients with B-Cell precursor acute lymphoblastic leukemia compared to chemotherapy. The data indicated that Blincyto resulted in a median overall survival of 7.7 months, compared to 4 months from chemotherapy.
The late-stage trial was conducted as a confirmatory study for an earlier mid-stage trial that supported Blincyto’s accelerated approval designation by the U.S. Food And Drug Administration (FDA) in 2014. Blincyto also demonstrated higher remission rates compared to chemotherapy. The drug also performed well on safety and tolerability measures. It has breakthrough therapy status and priority review designation from the U.S. FDA.
The company stock has shown strong performance as it gained over 21 percent this year so far. Its gain in the past 12 month stands at 20 percent. Amgen also recently announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial.
The trial met the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with KYPROLIS® and dexamethasone lived 7.6 months longer than those treated with Velcade® and dexamethasone.