Bayer AG is unblinding a phase 3 prostate cancer trial to analyze the higher rate of fractures and deaths in the arm using Bayer's therapy, as per the recommendation of an independent data monitoring committee.
The randomized double-blind, placebo-controlled ERA223 trial is evaluating the use of Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancer.
The primary goal of the trial is symptomatic skeletal event-free survival.
The company has informed relevant health authorities regarding the update on the trial as well as investigators of trials with Xofigo, or radium Ra 223 dichloride, and is preparing the respective information for healthcare professionals. Bayer is also gathering detailed study findings.
According to Bayer, data from other types of studies in which this combination treatment was evaluated did not show new safety signals.
"It is important to note that, based on available data from previous trials as well as real-world use, the benefit-risk profile of Xofigo in its approved indication remains favorable," said Mike Devoy, chief medical officer at Bayer.
