Japan-based Takeda Pharmaceutical has announced the termination of orteronel (TAK-700) development for prostate cancer in Japan, the US and Europe.
The company has voluntarily decided to end the development programme for orteronel following the results of two Phase III clinical trials in metastatic, castration resistant prostate cancer (mCRPC) patients.
Last month, Takeda reported data from the pivotal Phase III trial, ELM-PC4, in men with mCRPC who had not received chemotherapy.
The double-blind, randomised Phase III trial showed that orteronel plus prednisone improved radiographic progression free survival compared with 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.
In July 2013, Takeda announced that it has unblinded the ELM-PC 5 Phase III study of orteronel plus prednisone compared with placebo, plus prednisone in patients with mCRPC that had progressed during or following chemotherapy.
Takeda has unblinded the ELM-PC 5 Phase III study based on the recommendation of the Independent Data Monitoring Committee.
The pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival when compared with 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. In addition, there were no safety concerns.
Orteronel is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones.
Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical in Osaka, Japan. Photo: courtesy of J o.