Medivation Prevails in PREVAIL Study - Analyst Blog


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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.

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