Benefits observed in Phase III study of TAK 700 in Prostate Cancer - Takeda

Takeda Pharmaceutical has announced data from ELM-PC4, a pivotal, international, double blind, randomized Phase III trial showing that TAK 700 (orteronel) plus prednisone reduced the risk of radiographic progression free survival (rPFS), one of the study�s two primary endpoints, by 30 percent compared to placebo plus prednisone in men with chemotherapy-na�ve metastatic castration resistant Prostate Cancer (mCRPC) [median rPFS 11.0 v. 8.3 months]. The second primary endpoint, overall survival (OS), showed a numerical improvement in median OS of 1.9 months that was not statistically significant [median OS: 31.4 vs. 29.5 months].

Key secondary endpoints showed more patients experienced at least a 50 percent decrease in prostate-specific antigen and favorable circulating tumour cell (CTC) counts at 12 weeks in the treatment arm compared to the control. Common all-grade adverse events with orteronel and prednisone compared to control included nausea (36% vs. 15%), fatigue (34% vs. 20%), constipation (33% vs. 15%). Results from the study will be presented at the annual meeting of the American Society of Clinical Oncology.