Endocyte/Merck Withdraw EU Regulatory Filings - Analyst Blog

Endocyte, Inc. ECYT and partner Merck MRK withdrew their conditional marketing authorization applications CMA to the European Medicines Agency (EMA) for their oncology candidate, vintafolide, and companion imaging components − imaging agent etarfolatide and intravenous (IV) folic acid. The companies were looking to get the candidate approved in combination with pegylated liposomal doxorubicin PLD for the treatment of folate receptor-positive, platinum-resistant ovarian cancer.

Endocyte and Merck's decision to withdraw the applications was based on further analysis of data from the phase III PROCEED study. We remind investors that earlier this month, patient enrolment in the phase III PROCEED study on vintafolide was stopped following the Data Safety Monitoring Board's (DSMB) recommendation to discontinue the study since vintafolide did not meet the primary endpoint measured by progression-free survival PFS in patients suffering from platinum-resistant ovarian cancer. The companies intend to terminate this study.

Meanwhile, Endocyte and Merck are continuing to evaluate vintafolide in the phase IIb TARGET study in patients suffering from non-small cell lung cancer (NSCLC). The study will evaluate the safety and efficacy of vintafolide in second line NSCLC as a single agent and in combination with Taxotere. Results are expected in late 2014.

The failure of vintafolide in the ovarian cancer study is a major setback for Endocyte.  We expect investor focus to remain on pipeline updates from the company.

Endocyte carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Gilead Sciences Inc. GILD and Alexion Pharmaceuticals, Inc. ALXN. While Gilead carries a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).