Bayer HealthCare Pharmaceuticals Inc. today announced that the company has begun to enroll patients in a trial studying Xofigo…in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naive patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC). The randomized, double-blind, placebo-controlled Phase 3 trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival[i.e. that’s the primary endpoint].
The trial is expected to enroll 800 patients with primary-endpoint results in Jul 2017 (http://www.clinicaltrials.gov/ct2/show/NCT02043678 ). JNJ is cooperating with Bayer, which presumably means that Bayer doesn’t have to pay for the Zytiga used in the trial.