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Medivation Inc and Astellas Pharma Inc. Announce New Data From XTANDI (enzalutamide) Pivotal Study

Sunday, 30 Sep 2012 07:00am EDT 

Medivation Inc and Astellas Pharma Inc. announced that new data for enzalutamide (XTANDI capsules), an oral androgen receptor inhibitor, were presented at the 2012 European Society of Medical Oncology (ESMO) Annual Meeting in Vienna, Austria. The data from the randomized, global, placebo-controlled phase 3 AFFIRM study highlight the effect of enzalutamide on pain-related secondary endpoints and a post hoc analysis of the survival impact of baseline corticosteroid use among men with advanced prostate cancer. Findings from the corticosteroid analysis showed that patients in both the enzalutamide and the placebo groups taking glucocorticoids had an inferior survival compared to those who did not take glucocorticoids. Additionally, the pain-related data presented provide additional information to help those of us who treat prostate cancer on a daily basis to assess the benefits of enzalutamide for the individual patients. Baseline corticosteroid use was associated with reduced survival regardless of study treatment (i.e., enzalutamide or placebo). -- Enzalutamide was consistently superior to placebo on overall survival (OS), radiographic progression-free survival (rPFS) and time to PSA progression (TTPP) regardless of baseline corticosteroid use. -- After adjustment for the effects of other prognostic factors, the analysis demonstrated baseline corticosteroid use was still associated with poorer overall survival outcome. 

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