Takeda's orteronel trial unlikely to meet in CRPC
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said a pre-specified interim analysis of the Phase III ELM-PC 5 (C21005) trial showed twice-daily oral orteronel ( TAK-700) plus prednisone was unlikely to meet the primary endpoint of improving overall survival (OS) vs. placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) that has progressed during or following docetaxel-based therapy (HR=0.894, p=0.226). As a result, the pharma unblinded the trial. On the secondary endpoint of radiographic progression-free survival (PFS), Takeda said the interim analysis showed orteronel plus prednisone had an advantage over placebo plus prednisone (HR=0.755, p=0.00029).
Takeda said because of the observed improvement in radiographic PFS and the absence of safety concerns, it intends to give all patients in the trial the option to continue receiving orteronel. The double-blind, international trial enrolled about 1,083 metastatic CRPC patients. ...