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Takeda Pharmaceutical Co Ltd Announces Unblinding Of Phase 3 Study Of Orteronel In Patients With Metastatic, Castration-Resistant Prostate Cancer


Thursday, 25 Jul 2013 07:00pm EDT 

Takeda Pharmaceutical Co Ltd announced that it has unblinded the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed during or following chemotherapy based on the recommendation of the Independent Data Monitoring Committee (IDMC). The pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival (OS) when compared to the control arm (HR 0.894, p=0.226). The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm (HR 0.755, p=0.00029). In addition, there were no safety concerns. Takeda intends to allow all patients participating in the ELM-PC 5 study who were randomized to orteronel to continue on therapy following consultation with their physicians and study investigators. The appropriate health authorities and clinical study investigators are being notified that the ELM-PC 5 study has been unblinded. The decision to unblind the ELM-PC 5 study is not expected to impact other ongoing company-sponsored clinical trials with orteronel, including the ELM-PC 4 pivotal Phase 3 study (C21004) comparing orteronel plus prednisone to placebo plus prednisone in patients with chemotherapy-naive mCRPC. 

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20 Oct 2014