Unblinding Phase 3 Data for Zytiga May Soon Bring Second Prostate Cancer Indication

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(Chemotherapy Advisor) – Prednisone may soon have another clinical partner in the world of combination chemotherapy targeted against specific cancers. The news comes as an announcement that Janssen Research & Development, LLC, has unblinded its Phase 3 trial of Zytiga (abiraterone acetate) plus prednisone for the treatment of asymptomatic and mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy. Zytiga is already indicated for the treatment of metastatic castration-resistant prostate cancer (CRPC) for patients who received chemotherapy containing docetaxel. The recommendation to unblind the study came from the Independent Data Monitoring Committee (IDMC), who unanimously voted to showcase the data based on a planned interim analysis that revealed the study had met several of its efficacy endpoints and had favorable safety data.

In this international, randomized, double-blind, placebo-controlled study known as COU-AA-302, 1,088 patients were randomized into the treatment arm (1,000mg Zytiga, once daily, plus prednisone, 5mg, twice daily) or the placebo arm. The two co-primary endpoints for this article are radiographic progression-free survival and overall survival. Based on the success of Zytiga in meeting these two endpoints and yielding a favorable safety profile in this Phase 3 study, the IDMC recommended that patients in the placebo arm should also be offered treatment with Zytiga.  

Results of the study will be presented at an upcoming medical meeting and will be published in a peer-reviewed journal.


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