Investigational Vaccine Improves Survival in Glioblastoma Patients
Phase II data show up to 33% survival at 3 years (Nov. 15)
Three-year results have been reported from the phase II clinical program for rindopepimut (Celldex Therapeutics) in patients with epidermal growth factor receptor variant III (EGFRvIII)-positive glioblastoma — an aggressive form of glioblastoma typically associated with reduced long-term survival in comparison with the glioblastoma population as a whole.
Across three phase II studies, survival data suggest a continuing survival benefit with rindopepimut in comparison with control datasets at 3 years. In the multicenter ACT III study, the median overall survival period was 24.6 months from diagnosis (21.8 months from study entry), and overall survival was 26% at 3 years. In the ACT II study, the median overall survival period was 24.4 months from diagnosis (20.5 months from study entry), and overall survival was 23% at 3 years. In the ACTIVATE study, the median overall survival period was 24.6 months from diagnosis (20.4 months from study entry), and overall survival was 33% at 3 years.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule EGFRvIII — a mutated form of EGFR. EGFRvIII is expressed only in cancer cells and not in normal tissue, and is a transforming oncogene that can directly contribute to cancer cell growth. Expression of EGFRvIII is linked to poor long-term survival regardless of other factors, such as age and the extent of resection. EGFRvIII is expressed in approximately 30% of glioblastoma tumors.
Source: Celldex Therapeutics; November 15, 2012.