Celldex: RINTEGA Phase 2 Study Meets Primary Endpoint - Quick Facts

(RTTNews) - Celldex Therapeutics Inc. (CLDX) reported positive results from the randomized, double-blind Phase 2 study of RINTEGA (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma. The study met the primary endpoint of progression-free survival at six months, and a clear advantage was demonstrated across multiple, clinically important endpoints including overall survival, long-term progression-free survival, objective response rate and need for steroids.

RINTEGA is an investigational EGFRvIII specific therapeutic vaccine. ReACT is a randomized, controlled Phase 2 exploratory study designed to determine if adding RINTEGA to standard of care bevacizumab improves outcomes for patients with EGFRvIII-positive, recurrent glioblastoma across multiple measures. Investigator-reported interim data including study results through October 2014 were presented in late 2014.

The company previously announced its intention to discuss the potential significance of the ReACT study with regulatory bodies if updated data remained consistent with previously reported results. Celldex said, given the consistency of the results, the process is ongoing, and it will communicate the outcome of these discussions when they are completed.