On May 14, 2014, Takeda announced results from ELM-PC 4, a pivotal, international, double blind, randomized phase III trial in men with metastatic, castration-resistant prostate cancer who had not received chemotherapy, which showed that orteronel plus prednisone improved radiographic progression-free survival compared to prednisone alone, one of the study's two primary endpoints, but did not show a statistically significant improvement in the study's second primary endpoint of overall survival.

Earlier Findings

A previously reported phase III trial, ELM-PC 5, in men with metastatic, castration-resistant prostate cancer that had progressed during or following chemotherapy, was unblinded in 2013 after a prespecified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival when compared to the control arm. The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint—radiographic progression-free survival—over the control arm. There were no significant safety concerns in either study.

Takeda is in communication with trial investigators and the relevant regulatory authorities, to provide them with updated and current information in compliance with local regulations. Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the orteronel (TAK-700) trials are transitioned to appropriate therapies so that trial participants receive appropriate care. Patients enrolled in the orteronel (TAK-700) clinical trials are urged to consult their study investigators to address any questions, and before making any changes to their medication. For additional information, visit www.takeda.com.