Radium 223 and abiraterone combo safety issues
Bayer has been forced to unblind a trial looking at the combination of radium 223 (Xofiga) and abiraterone (Zytiga) in asymptomatic or mildly symptomatic chemotherapy-naïve bone-predominant metastatic castration-resistant prostate cancer after an excess of deaths and fractures were noted in the combination group compared to the abiraterone group alone.
The phase 3 trial in 806 patients had been running since 2016 and so patients in the combination group had all already received the specified six doses of radium 223. Therefore, study patients are continuing on abiraterone as per the study protocol. As is standard practice abiraterone is always given with prednisone or prednisolone.
According to Bayer the unblinding will enable a thorough examination of all the data. Healthcare professionals and patients taking part in the trial will be updated as more information becomes available, it says.
Mike Devoy, the Chief Medical Officer at Bayer says, ‘It is important to note that, based on available data from previous trials as well as real-world use, the benefit-risk profile of radium 223 in its approved indication remains favourable.’