Safety Concerns Make Bayer Unblind Prostate Cancer Trial of Xofigo Combination

Safety Concerns Make Bayer Unblind Prostate Cancer Trial of Xofigo Combination
An Independent Data Monitoring Committee has asked Bayer to unblind a Phase 3 clinical trial of a Xofigo (radium-223)-based therapy for prostate cancer after data indicated more bone fractures in study participants. The study randomly assigned prostate cancer patients to treatment with Xofigo or a placebo — both given in combination with Zytiga (abiraterone acetate) and prednisone or prednisolone. Neither patients nor study staff were aware of the treatment assignment — a set-up called blinding. To allow a proper examination of the potential safety issue, scientists, however, need to know which patients received Xofigo. For now, patients will continue to be monitored according to the study protocol while researchers examine the data identified by the monitoring committee. "Patient safety is our top priority. We are therefore unblinding the study to thoroughly analyze the data," Mike Devoy, a member of the Pharmaceuticals' Division Executive Committee and chief medical officer at Bayer, said in a press release. Meanwhile, the company underscored that earlier studies of this combination treatment had not spotted any safety issues. “It is important to note that, based on available data from previous trials as well as real-world use, the benefit-risk profile of Xofigo in its approved indication remains favorable. We remain committed to further exploring the potential of radium-223 across multiple tumor types with significant unmet medical need, including prostate cancer," Devoy said. The Phase 3 trial, called ERA 223 (
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