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Endocyte Reports DSMB Recommendations Following Interim Futility Analysis

Endocyte, Inc. (ECYT: Quote) unveiled the outcomes of the planned independent Data Safety Monitoring Board or DSMB review of the interim futility analysis for the Phase 2b TARGET study with investigational candidate vintafolide. The DSMB urged the continuation of the vintafolide combination therapy and docetaxel monotherapy arms of the trial.

In addition, the DSMB recommended investigators and patients be advised that vintafolide monotherapy is not likely to be declared superior to docetaxel in progression-free survival or PFS at the end of the study, and patients currently on vintafolide monotherapy may continue treatment based on guidance from their investigator. The TARGET trial's top-line results are expected in early 2014.

TARGET is being conducted in non-small cell lung cancer patients with all lesions expressing the folate receptor, as determined by the investigational companion imaging agent etarfolatide. This randomized trial is fully enrolled and comprised two investigational arms, vintafolide monotherapy and vintafolide in combination with docetaxel, each of which is compared to a standard of care control arm, docetaxel monotherapy.

The primary endpoint of the trial is PFS, powered to show a 50 percent improvement in PFS compared to the control arm, while secondary endpoints include the comparison of overall response rate, overall survival and safety.

by RTT Staff Writer

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