OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) today announced data from ELM-PC4, a pivotal, international, double blind, randomized Phase 3 trial showing that the investigational drug 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-naïve metastatic castration resistant prostate cancer (mCRPC) [median rPFS 11.0 v. 8.3 months (HR 0.7; 95% CI:0.5-0.8; P<0.001)]. 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 (HR 0.9; 95% CI: 0.8-1.1; P=0.314)]. Results from the study will be presented as an oral presentation on June 1 during the Genitourinary (Prostate) Cancer session at the annual meeting of the American Society of Clinical Oncology (ASCO).
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