Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has unblinded the Phase III 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, showing that the combination significantly delayed the growth of prostate cancer and helped patients live longer compared to placebo.
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 5mg administered twice daily or placebo plus prednisone 5mg administered twice daily. The co-primary endpoints of the study are radiographic progression-free survival and overall survival.
IDMC proposes placebo patients be moved to treatment arm
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