Results from Phase III ALSYMPCA trial of Xofigo (Bayer HealthCare) for Prostate Cancer published in NEJM

Data from the pivotal Phase III ALSYMPCA trial of Xofigo (radium Ra 223 dichloride), from Bayer HealthCare, in castration-resistant Prostate Cancer (CRPC) patients with symptomatic bone metastases are published in the New England Journal of Medicine. In the trial, which enrolled 921 patients, Xofigo significantly improved Overall Survival at the pre-specified interim analysis; median OS was 14.0 months with Xofigo vs. 11.2 months with placebo.

In an exploratory analysis with an additional 214 events before patient cross-over, Xofigo showed median OS was 14.9 months vs 11.3 months in the placebo arm. The most common adverse drug reactions were nausea, diarrhea and vomiting. See: "Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer." Parker C, et al. N Engl J Med. 2013;369:213-23. Xofigo was approved by the FDA in May 2013.