In a surprise announcement today Bayer Healthcare announced that an Independent Data Monitoring Committee (IDMC) has recommended that they un-blind their Phase III trial of radium 223 dichloride (Xofigo) in combination with abiraterone acetate (Zytiga) and prednisone in men with castrate resistant prostate cancer.
The IDMC recommendation is a result of their observation that there were more fractures and deaths in the experimental treatment arm than in the control group.
Bayer is following the IDMC’s recommendation and un-blinding the study. They will then analyze the results and continue monitoring as per study protocol.
What has added to the confusion is that data from other types of studies in which this combination treatment was evaluated did not show new safety signals.
The role of the IDMC is to take periodic “behind the scene” looks at the data. Their goal is to stop any trials that might be hurting individuals, alerting the pharmaceutical company if there are any signals that the trial seems to be futile (not going to yield positive results) or if the trial seems to have demonstrated the results that are so positive that it can be stopped prior to all the endpoints having been reached.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.