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Astellas-Medivation's Xtandi Meets Primary Endpoint - Analyst Blog

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Astellas Pharma Inc. ALPMY and Medivation, Inc. MDVN announced positive top-line results from a phase II study (STRIVE), which compared Xtandi to Casodex in patients suffering from non-metastatic or metastatic castration-resistant prostate cancer (CRPC). The study has achieved its primary endpoint of progression-free survival (PFS).

In this study, Xtandi showed a statistically significant increase in PFS compared to Casodex in CRPC patients, whose disease progressed despite treatment with a luteinizing hormone-releasing hormone analogue therapy or after surgical castration. Median PFS among the patients treated with Xtandi was 19.4 months whereas that in the Casodex arm was only 5.7 months. The median time on treatment was 14.7 months in the Xtandi group compared to 8.4 months in the Casodex group.

However, 29.4% of patients administered with Xtandi reported serious adverse events versus 28.3% of the Casodex-treated patients. Grade 3 or higher cardiac adverse events were also reported by 5.1% of the patients in the Xtandi-arm patients compared to 4% in the Casodex arm. Additionally, one patient under Xtandi treatment reported seizure.

We note that XTANDI is already approved for the treatment of metastatic CRPC in the U.S. and Europe and CRPC in Japan. In 2014, the drug generated net sales of approximately $1.1 billion (as reported by Astellas). Based on results from the STRIVE study, Astellas and partner Medivation believes that Xtandi has the potential to provide a longer duration disease control compared to Casodex.

Meanwhile, Astellas has been quite active on the collaborations front. Late last week, the company announced the signing of an option agreement with the MD Anderson Cancer Center of The University of Texas for the research and development of a monoclonal antibody therapy targeting acute myeloid leukemia.

Under this collaboration, Astellas obtained an option to negotiate an exclusive, worldwide license at the end of the phase Ib study (both phase Ia and phase Ib studies are to be conducted by MD Anderson). The deal includes up to $26 million to be paid as an option premium and research and development funding.

Astellas carries a Zacks Rank #2 (Buy). Other favorably-ranked stocks in the health care sector include Lannett Company, Inc. LCI and Cytokinetics, Inc. CYTK . Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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