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Study Unblinded: ZYTIGA® (abiraterone acetate) Plus Prednisone for Asymptomatic or Mildly Symptomatic Chemotherapy-Naive Patients with Metastatic Castration-Resistant Prostate Cancer
Date:3/8/2012

RARITAN, N.J., March 8, 2012 /PRNewswire/ -- Janssen Research & Development, LLC today announced that it has unblinded the Phase 3 study of ZYTIGA® (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy.  

Study COU-AA-302 is an international, randomized, double-blind, placebo controlled study that included 1,088 patients who were randomized to receive ZYTIGA 1,000 milligrams (mg) administered once daily plus prednisone 5 mg administered twice daily or placebo plus prednisone 5 mg administered twice daily. The co-primary endpoints of the study are radiographic progression-free survival and overall survival.

The Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the study based on a planned interim analysis in which differences in radiographic progression-free survival, overall survival, and secondary endpoints were observed that constitute evidence of clinical benefit as well as continued evidence of favorable safety in patients receiving abiraterone acetate plus prednisone as compared to those receiving placebo plus prednisone.  Based on these results, the IDMC also recommended that patients in the placebo arm be offered treatment with ZYTIGA.

These results will be presented at an upcoming medical meeting and will also be submitted for publication in a peer-reviewed journal.

"The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of ZYTIGA in metastatic prostate cancer," said William N. Hait, MD, PhD, Global Head, Janssen R&D.  "We're delighted that these data will soon be added to the growing body of literature about this important medication."

ZYTIGA has not been approved for use in men with metastatic CRPC who have not yet received chemotherapy.  The company plans to s
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SOURCE Janssen Research & Development, LLC
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