WHIPPANY, N.J., Nov. 30, 2017 /PRNewswire/ — Bayer today announced that an Independent Data Monitoring Committee (IDMC) has recommended to unblind a Phase III trial of radium Ra 223 dichloride (radium-223) in combination with abiraterone acetate and prednisone/prednisolone in prostate cancer. The IDMC recommendation is due to the observation of an imbalance of more fractures and deaths in the treatment arm investigating radium-223 in combination with abiraterone and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic, chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Bayer is now unblinding the study per the IDMC’s recommendation and will thoroughly analyze the findings and continue monitoring as per study protocol. Data from other types of studies in which this combination treatment was evaluated did not show new safety signals.
“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