Astellas Pharma Inc. (ALPMY) and partner Medivation, Inc. (MDVN) recently announced that the companies have established an updated interim analysis plan for an ongoing phase III study (:PREVAIL), which is evaluating Xtandi (enzalutamide) in chemotherapy-naive prostate cancer patients. This interim analysis for the study is expected to be conducted during the course of the year.
The randomized, placebo-controlled, double-blind, multi-national trial includes 1,717 patients across the US, Canada, Europe, Australia and Israel. The study has two primary endpoints: radiographic overall survival (:OS) and progression-free survival (PFS). Secondary endpoints include time to first skeletal-related event and time to initiation of chemotherapy. The trial is evaluating Xtandi at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.
We note that Xtandi (160 mg once daily) is already available in the US since Sep 2012 for the treatment of castration-resistant prostate cancer that has spread to other parts of the body. The patients have already been treated with Sanofi’s (SNY) cancer drug Taxotere. It was approved by US Food and Drug Administration (:FDA) in Aug 2012. The approval was based on encouraging results from a randomized, placebo-controlled, multicenter phase III study (:AFFIRM) which evaluated the safety and efficacy of the drug versus placebo. The study not only met primary and secondary endpoints but Xtandi’s safety profile was also found favorable.
Astellas Pharma carries a Zacks Rank #4 (Sell) while Medivation carries a Zacks Rank #3 (Hold). Currently, Lannett Company, Inc.(LCI) looks more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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