J&J's Zytiga meets in Phase II/III STAMPEDE trial for hormone-naïve prostate cancer

Johnson & Johnson (NYSE:JNJ) reported data from the Phase II/III STAMPEDE trial in 1,917 patients with high-risk, locally advanced or metastatic hormone-naïve prostate cancer showing that Zytiga abiraterone acetate (CB7630) plus androgen deprivation therapy met the primary endpoint of improving overall survival (OS) vs. androgen deprivation therapy alone at a median follow-up of 40 months (184 vs. 262 deaths, HR=0.63, 95% CI: 0.52, 0.76, p<0.001). The 3-year survival rate was 83% for Zytiga plus androgen deprivation therapy vs. 76% for androgen deprivation therapy alone.

The trial enrolled 509 patients with newly diagnosed node-negative, non-metastatic disease; 369 patients with newly diagnosed node-positive, non-metastatic disease; 941 patients with newly diagnosed metastatic disease; 37 patients with previously treated non-metastatic disease; and 61 patients with previously treated metastatic disease. The OS hazard ratio was 0.75 in patients with non-metastatic disease and 0.61 in patients with metastatic disease...