Updated on 9 August 2012
Updated data from the pivotal phase III alpharadin in symptomatic prostate cancer (ALSYMPCA) trial for its investigational drug Alpharadin (radium-223 dichloride) confirms the overall survival benefit in men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases as compared to the interim analysis from June 2011.
The updated data showed that radium-223 dichloride improved overall survival by 44 percent, resulting in a 30.5 percent reduction in the risk of death as compared to placebo. The median overall survival benefit with radium-223 dichloride 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 radium-223 dichloride versus 11.3 months with placebo)
The overall safety and tolerability profile for radium-223 dichloride was consistent with previous study results. It is notable that the US FDA also granted fast-track approval to the radium-223 dichloride NDA.
A majority of men with CRPC have radiological evidence of bone metastases. The five-year survival rate in patients with prostate cancer with bone metastases is three percent. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man's health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of disability and death in patients with CRPC.
Bone metastases are one of the main causes of disability and death in patients with castration-resistant prostate cancer, however, until now there has been little progress made towards developing therapies that target the cancer when it has spread to the bone. Radium-223 dichloride is the first therapy specifically addressing prostate cancer that has spread to the bone, which has shown to significantly improve the overall survival in a phase III trial. It offers new hope for patients for whom options are limited.