Medivation Prevails in PREVAIL Study - Analyst Blog
January 29 2014 - 1:50PM
Zacks
Medivation Inc. (MDVN) and partner
Astellas Pharma Inc. (ALPMY) continue to come out
with positive data on their prostate cancer therapy, Xtandi
(enzalutamide). The companies presented final results from the
phase III randomized, double-blind, placebo-controlled,
multi-national PREVAIL study which was conducted in chemo-naïve
metastatic prostate cancer patients who had failed androgen
deprivation therapy and had few or no symptoms.
The results are pretty impressive with Xtandi reducing the risk
of death by 29% compared to placebo. Moreover, the risk of
radiographic progression or death was cut by 81% in the Xtandi arm.
A 17-month delay in the time to initiation of chemotherapy was
observed in the Xtandi arm.
Medivation also reported that most of the men with soft tissue
metastatic disease had objective responses in the Xtandi arm
compared to placebo (58.8% versus 5%) – complete response was
observed in 19.7% of patients in the Xtandi arm compared to just 1%
in the placebo arm.
The median time to PSA progression was extended from 2.8 months
in the case of placebo to 11.2 months in the case of Xtandi. About
78% of patients in the Xtandi arm saw a PSA decline of ≥50%
compared to less than 4% in the placebo arm.
Xtandi is currently approved for the treatment of patients with
metastatic castration-resistant prostate cancer who have previously
received docetaxel.
Our Take
Medivation had presented encouraging interim data from the
PREVAIL study last year. The recently released full data confirms
the interim results and will allow the companies to go ahead and
file for approval shortly. Expansion into the pre-chemo setting
will be a major positive for Medivation. The 17-month delay in the
time to initiation of chemotherapy should help Xtandi gain share
once it is approved for the pre-chemo patient population.
Medivation is a Zacks Rank #1 (Strong Buy) stock. Some other
stocks worth considering in the health care sector include
Actelion Ltd. (ALIOF) and Affymetrix
Inc. (AFFX). Both are Zacks Rank #1 stocks.
AFFYMETRIX INC (AFFX): Free Stock Analysis Report
ACTELION LTD (ALIOF): Get Free Report
ASTELLAS PHARMA (ALPMY): Get Free Report
MEDIVATION INC (MDVN): Free Stock Analysis Report
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