Bayer reports mortality signal with Xofigo in early CRPC

Bayer AG (Xetra:BAYN) said an IDMC observed more fractures and deaths among patients treated with Xofigo radium-223 dichloride vs. placebo in the Phase III ERA223 trial to treat metastatic castration-resistant prostate cancer. Bayer said it will unblind the study data.

The trial's 806 patients with chemotherapy-naive, symptomatic or mildly symptomatic metastatic CRPC received 50 kBq/kg IV Xofigo or placebo for six four-week cycles in combination with Zytiga abiraterone acetate abiraterone and prednisone/prednisolone. The trial's primary endpoint is to evaluate symptomatic skeletal event-free survival (SSE-FS) at three years...