Algeta announced that updated data from the phase III trial, ALSYMPCA, for its investigational drug Alpharadin (radium-223 dichloride). The data confirmed the overall survival of men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases using Alpharadin, compared to the interim analysis from June 2011.
• Overall survival in Alpharadin arm increased by 44%
• Median survival benefit increased to 3.6 months
• Significantly delayed time to first skeletal-related event (SRE)
• Submissions seeking marketing approval in US & Europe expected in 2H 2012
The updated data showed that Alpharadin improved overall survival by 44% (p=0.00007, HR=0.695), resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival benefit with Alpharadin was 2.8 months at the time of the interim analysis in June 2011 and 3.6 months in this updated analysis (14.9 months in patients given Alpharadin vs. 11.3 months with placeb