Multinational phase 3 study of abiraterone-prednisone plus apalutamide or placebo for mCRPC

The multinational phase 3 ACIS study evaluated addition of apalutamide or placebo to abiraterone acetate plus prednisone for metastatic castration-resistant prostate cancer. The median radiographic progression-free survival was 22.6 months with apalutamide-abiraterone-prednisone versus 16.6 months with placebo-abiraterone-prednisone (HR 0.69; p<0.0001). Serious treatment-emergent adverse events occurred in 40% versus 37%. The authors conclude that despite the use of an active and established therapy as the comparator, addition of apalutamide improved rPFS.