Takeda Unveils Phase 3 ELM-PC4 Trial Data in Men With Chemotherapy-Naive mCRPC

Orteronel combined with prednisone showed significant PFS but not OS in a double-blind, randomized phase 3 trial.

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 vs. 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).

“The significant rPFS advantage observed for orteronel combined with prednisone in the ELM-PC4 study is consistent with the previously reported rPFS improvement observed in the ELM-PC5 study, where orteronel was also studied with prednisone in men with mCRPC who had previously received chemotherapy. We are carefully analyzing these data to fully inform future decisions in the orteronel program,” said Michael Vasconcelles, M.D., Global Head, Takeda Oncology Therapeutic Area Unit. “We thank and express our gratitude to the patients, their families and the study investigators for their significant contributions to the orteronel program to date.”

Read the press release here: http://bit.ly/1vug1xS

Source: Takeda