Mixed results for Takeda's orteronel in CRPC
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said twice-daily oral orteronel ( TAK-700) plus prednisone met one co-primary endpoint but missed the other vs. placebo plus prednisone in the Phase III ELM-PC4 trial to treat metastatic castration-resistant prostate cancer (CRPC) in chemotherapy-naïve patients. Orteronel plus prednisone improved median radiographic progression-free survival (PFS) vs. placebo plus prednisone (11 vs. 8.3 months, p<0.001) but did not improve median overall survival (OS) vs. placebo plus prednisone (31.4 vs. 29.5 months, p=0.314). The double-blind, international trial enrolled 1,560 chemotherapy-naïve patients with progressive metastatic CRPC. Data will be presented at the American Society of Clinical Oncology meeting. ...