Bayer unblinds prostate cancer combo trial early due to AEs

German pharma major Bayer (BAYN: DE) this morning revealed a setback in its development of a combination therapy for prostate cancer.

The company said that an Independent Data Monitoring Committee (IDMC) has recommended to unblind a Phase III trial of radium Ra 223 dichloride (radium-223; marketed under the trade name Xofigo) in combination with abiraterone acetate and prednisone/prednisolone in prostate cancer.

The IDMC recommendation is due to the observation of an imbalance of more fractures and deaths in the treatment arm investigating radium-223 in combination with abiraterone and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic, chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Bayer is now unblinding the study per the IDMC's recommendation and will thoroughly analyze the findings and continue monitoring as per study protocol. Data from other types of studies in which this combination treatment was evaluated did not show new safety signals.