Bayer reports mortality signal in Phase III of Xofigo in early CRPC

Bayer AG (Xetra:BAYN) said it will unblind early the Phase III ERA223 trial to treat metastatic castration-resistant prostate cancer (CRPC) after an an IDMC observed more fractures and deaths among patients treated with Xofigo radium-223 dichloride (BAY88-8223) compared to placebo. Bayer said Xofigo dosing in the study is complete.

The trial's 806 patients with asymptomatic or mildly symptomatic, chemotherapy-naïve bone predominant metastatic CRPC received 50 kBq/kg IV Xofigo or placebo for six 4-week cycles in combination with Zytiga abiraterone acetate and prednisone/prednisolone.The trial's primary endpoint is to evaluate symptomatic skeletal event-free survival at 3 years. Secondary endpoints in the trial include overall survival (OS), time to opiate use for cancer pain, time to pain progression, time to cytotoxic chemotherapy, radiological progression-free survival (rPFS) and safety...