publication date: Apr. 30, 2015

Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer 


Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.

The companies also published data from two separate phase II head-to-head studies, named STRIVE and TERRAIN, comparing Xtandi (enzalutamide) to Casodex (bicalutamide).

The phase III trial, named PREVAIL, was a randomized, double-blind trial that enrolled 1,717 patients at sites in the U.S., Canada, Europe, Australia, Russia, Israel and Asia, including Japan.

The trial enrolled patients with chemotherapy-naive metastatic prostate cancer whose disease progressed on androgen deprivation therapy (i.e., a LHRH therapy or after bilateral orchiectomy).

The co-primary endpoints of the trial were overall survival and radiographic PFS. The trial was designed to evaluate Xtandi at a dose of 160 mg taken orally once daily versus placebo.

The updated overall survival analysis was conducted at 784 deaths and found a statistically significant overall survival benefit with a 23 percent reduction in risk of death (OS: HR 0.77; 95% CI 0.67-0.88; p=0.0002) and a four-month improvement in median survival with Xtandi (35.3 months [95% CI 32.2 – not yet reached]) over placebo (31.3 months [95% CI 28.8 – 34.2]).

As of the June 2014 cut-off date with a median follow-up duration of 31 months: 52 percent of Xtandi and 81 percent of placebo patients received one … Continue reading CCL April – Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer

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