Celldex reports interim positive results from rindopepimut Phase 2b study for GBM at ASCO

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that interim results from a Phase 2b study evaluating rindopepimut (formerly PF-04948568 or CDX-110) in newly-diagnosed glioblastoma multiforme (GBM) patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Rindopepimut, an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII), was developed by Celldex Therapeutics and is licensed to Pfizer.

“Prognostic effect of epidermal growth factor receptor and EGFRvIII in glioblastoma multiforme patients.”

"We are pleased that interim data from ACT III is consistent with data generated from our two previous clinical studies with rindopepimut in GBM," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "70 percent of ACT III patients were progression-free at 5.5 months after initiating treatment with rindopepimut, which corresponds to the 8.5 months seen in ACT II and ACTIVATE when measured from diagnosis and surgery. The earlier ACTIVATE and ACT II trials reported progression free rates at 8.5 months of 70 and 80 percent, respectively. Importantly, previous studies were conducted in just a few leading centers, whereas ACT III enrolled patients in over 25 centers in the United States. We look forward to the final ACT III data later this year, and are working with Pfizer to determine appropriate next steps in the development of rindopepimut."

Approximately 10,000 patients are diagnosed with GBM annually in the United States, and it is estimated that the EGFRvIII mutation may be expressed in approximately 25 to 30 percent of the GBM population. Based upon historic controls from Duke/MDACC, median progression free survival for patients with EGFRvIII positive GBM is 6.3 months.

SOURCE Celldex Therapeutics, Inc.