What's killing pa­tients in Bay­er's Xofi­go com­bo study? Re­searchers un­blind study ear­ly to probe safe­ty alert

Back in the spring of 2016, re­searchers re­port­ed that a com­bi­na­tion of Bay­er’s Xofi­go (ra­di­um-223) with Zyti­ga (abi­raterone) came through with ev­i­dence of sig­nif­i­cant­ly re­duced bone pain for men suf­fer­ing from prostate can­cer. But sci­en­tists were forced to un­blind the Phase III piv­otal tri­al pre­ma­ture­ly af­ter an in­de­pen­dent mon­i­tor­ing group spot­ted a high­er rate of deaths in the treat­ment arm.

The com­pa­ny, which has been pur­su­ing new can­cer drugs as a core ap­proach to pipeline con­struc­tion, had en­rolled 806 pa­tients who ei­ther got the com­bo or just Zyti­ga, a well es­tab­lished block­buster that helped change the stan­dard of care in prostate can­cer.

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