Disappointment for Takeda as Ph III prostate cancer trial fails
Japan’s largest drugmaker Takeda Pharma (TYO: 4502) has unblinded a Phase III study after analysis showed that orteronel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC), would not improve overall survival.
The ELM-PC 5 Phase III study compared orteronel, a non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones, plus prednisone to placebo plus prednisone in patients with mCRPC which had progressed during or following chemotherapy. It has been unblended on the recommendation of the Independent Data Monitoring Committee (IDMC).
While the primary endpoint of improved overall survival was not met, the interim analysis showed an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival over the control arm. There were also no safety concerns.
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