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

Johnson & Johnson (NYSE:JNJ) reported data from the Phase III LATITUDE trial in 1,199 patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer showing that Zytiga abiraterone acetate (CB7630) plus androgen deprivation therapy met the co-primary endpoints of improving overall survival (OS) and radiographic progression-free survival (PFS) vs. placebo plus androgen deprivation therapy at a median follow-up of 30.4 months. Specifically, median OS was not reached in the Zytiga plus androgen deprivation therapy arm vs. 34.7 months for placebo plus androgen deprivation therapy (HR=0.62, 95% CI: 0.51, 0.76, p<0.001). Additionally, Zytiga plus androgen deprivation therapy led to a median radiographic PFS of 33 months vs. 14.8 months for placebo plus androgen deprivation therapy (HR=0.47, 95% CI: 0.39, 0.55, p<0.001).

Zytiga plus androgen deprivation therapy also met the secondary endpoints of improving time to pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, prostate-specific antigen (PSA; KLK3) progression (p<0.0001 for all) and next symptomatic skeletal-related event (p=0.0086) vs. placebo plus androgen deprivation therapy. Data were presented at the American Society of Clinical Oncology meeting in Chicago and published in the New England Journal of Medicine...