"Patient safety is our top priority. We are therefore unblinding the study to thoroughly analyze the data," said Mike Devoy, Member of the Pharmaceuticals' Division Executive Committee and Chief Medical Officer at Bayer. "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. We remain committed to further exploring the potential of radium-223 across multiple tumor types with significant unmet medical need, including prostate cancer."This Phase III trial evaluates the investigational use of radium Ra 223 dichloride in combination with abiraterone acetate and prednisone/prednisolone compared to placebo plus abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancer (CRPC). The primary endpoint of the trial is symptomatic skeletal event-free survival (SSE-FS). The trial completed enrollment in September 2016, therefore no patients in the combination arm are receiving radium Ra 223 dichloride which is only administered for up to 6 doses (one dose every 4 weeks).
Bayer has informed relevant health authorities regarding the study unblinding as well as investigators of trials with radium Ra 223 dichloride and is preparing the respective information for healthcare professionals. In addition, the company is in the process of gathering the detailed study findings and will update health authorities and healthcare professionals accordingly.
For further information, patients should contact their healthcare professionals.
Since its approval in 2013, more than 18,000 U.S. patients1 have been treated with radium-223. The benefit-risk profile demonstrated in the Phase III ALSYMPCA trial which resulted in the approval of Xofigo remains favorable.
Phase III Trial Design
The randomized double-blind, placebo-controlled Phase III trial ERA223 was designed to investigate whether providing radium Ra 223 dichloride (radium-223) in combination with abiraterone acetate and prednisone/prednisolone will extend symptomatic skeletal event free survival (SSE-FS). The trial has enrolled 806 patients who were randomized in a 1:1 ratio to receive either study treatment of radium-223 dichloride for six cycles with abiraterone acetate plus prednisone/prednisolone or placebo for six cycles with abiraterone acetate plus prednisone/prednisolone and best supportive care. Patients in both arms were scheduled to receive treatment with abiraterone acetate plus prednisone/prednisolone until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met). For further information about the study, please visit www.clinicaltrials.gov