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news.US-based Janssen Research & Development (R&D) has unblinded the Phase 3 study of Zytiga (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC).
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An international randomized double-blind placebo controlled Study COU-AA-302 included 1,088 patients who were randomized to receive Zytiga 1,000mg once daily plus prednisone 5mg administered twice daily or placebo plus prednisone 5mg administered twice daily.
In the trial, the co-primary endpoints were radiographic progression-free survival and overall survival.
Independent Data Monitoring Committee (IDMC) recommend to unblind the clinical study at an interim analysis based on predetermined criteria, such as efficacy endpoints and the risk/benefit profile, as well as ethical considerations.
Janssen R&D global head William N. Hait said the COU-AA-302 study has been a key priority for the understanding of the utility of Zytiga in metastatic prostate cancer.
The company plans to submit for regulatory approval in the US and around the world beginning in the second half of this year.
Zytiga plus prednisone has been approved by the US Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.