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Trials & Filings

Endocyte To Continue NSCLC Study

Vintafolide not likely to be superior to docetaxel as monotherapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Endocyte will continue its non-small cell lung cancer (NSCLC) trial of vintafolide after an independent Data Safety Monitoring Board (DSMB) review of the interim futility analysis for the Phase IIb trial. The DSM recommended the continuation of two arms of the trial, vintafolide combination therapy (investigational) and docetaxel monotherapy (control), but recommended that investigators and patients be advised that vintafolide monotherapy is not likely to be declared superior to docetaxel in progression-free survival (PFS) at the end of the study. The DSMB suggested that patients currently in the vintafolide monotherapy arm may continue treatment based on guidance from their investigator.

The study’s primary endpoint is PFS, powered to demonstrate a 50 percent improvement in PFS (hazard ratio of 0.67) compared to the control arm. Secondary endpoints include the comparison of overall response rate, overall survival and safety. Top-line results from the trial are expected in early 2014. Merck is responsible for the development and worldwide commercialization of vintafolide. Endocyte intends to co-promote vintafolide in the U.S. pending regulatory filing and approval, and is responsible for the development, manufacture and commercialization of etarfolatide worldwide.

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