A phase 3 study of Johnson & Johnson unit Janssen Research & Development LLC's Zytiga, or abiraterone acetate, showed significant clinical benefit in patients with high-risk metastatic hormone-naive prostate cancer.
Abiraterone acetate plus prednisone in combination with androgen deprivation therapy, or ADT, showed a significant improvement in overall survival and significantly prolonged radiographic progression-free survival, or rPFS, compared to placebo plus ADT.
According to study findings, the combination therapy reduced the risk of death by 38% compared to placebo plus ADT. Median overall survival for the experimental arm was not reached while the median overall survival for the control arm was 34.7 months. Study results also showed that the combination therapy reduced the risk of progression or death rPFS by 53% compared to placebo plus ADT. Median rPFS was 33 months for the experimental arm compared to 14.8 months for the control arm.
The study also met all secondary endpoints with statistically significant improvements in times to pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, prostate-specific antigen progression, and symptomatic skeletal events.