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).
DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Saturday, July 27, 2013
Targeted failure of the week. Post No 93. Orteronel
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).
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