Endocyte Receives DSMB Recommendation for Continuation of Vintafolid/Docetaxel Combo
Endocyte, Inc. (Nasdaq: ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced the outcomes of the planned independent Data Safety Monitoring Board (DSMB) review of the interim futility analysis for the Phase 2b TARGET trial with investigational candidate vintafolide (MK-8109/EC145). The DSMB recommended the continuation of the vintafolide combination therapy and docetaxel monotherapy arms of the trial. The DSMB also recommended 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, and patients currently on vintafolide monotherapy may continue treatment based on guidance from their investigator. Top-line results from the TARGET trial are expected in early 2014.
TARGET is being conducted in non-small cell lung cancer (NSCLC) patients with all lesions expressing the folate receptor (FR100%), as determined by the investigational companion imaging agent etarfolatide (EC20). This randomized trial is fully enrolled and included two investigational arms, vintafolide (MK-8109/EC145) monotherapy and vintafolide in combination with docetaxel, each of which is compared to a standard of care control arm, docetaxel monotherapy. 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.
"We are very pleased that our combination therapy of vintafolide and docetaxel successfully passed the pre-defined interim analysis, and we look forward to announcing the top-line results of this trial early next year," said Binh Nguyen, M.D., Ph.D., vice president of clinical development at Endocyte. "The DSMB's recommendation to allow for continued treatment in the vintafolide single-agent arm enhances our opportunity to gain important information about single agent efficacy and safety to inform future trials."
Endocyte and partner Merck have accepted the DSMB recommendations and are informing investigators. This includes guidance that, per study protocol, investigators are required to follow all patients whether they continue therapy or not for documentation including overall survival. The companies remain blinded to the study results.
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