The decision was taken as the studies showed that orteronel plus prednisone could extend the time patients lived before their cancer progressed but failed to extend overall survival of patients.
The company has decided that the medicine has not exhibited a clinical profile sufficient to move forward in mCRPC, given the availability of other therapies.
Takeda’s ELM-PC4 Phase 3 trial in men with mCRPC who had not received chemotherapy, demonstrated that orteronel plus prednisone improved radiographic progression free survival (rPFS) compared to prednisone alone. This was one of the two primary endpoints of the study.
The double blind and randomized Phase 3 trial, however, failed to show a statistically significant improvement in the study’s second primary endpoint, which includes overall survival (OS).
In 2013, ELM-PC5, a previously reported Phase 3 trial, in men with mCRPC that had progressed during or following chemotherapy was unblinded after a pre-specified interim analysis pointed that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival when compared to the control arm.
The interim analysis demonstrated an advantage for orteronel plus prednisone for the trial’s secondary endpoint of radiographic progression-free survival over the control arm.
There were no significant safety concerns in either study, according to the company.
Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical in Osaka, Japan. Photo: Courtesy of J o