Astellas Pharma Inc.
) and partner
) 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
) 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.
) looks more attractive in the pharma space with a Zacks Rank #1
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