Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that patient screening has initiated in a Phase 2 trial of rindopepimut in combination with Avastin® in patients with recurrent epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, called the "ReACT Study." This new study will run in parallel with Celldex's Phase 3 trial (ACT IV) evaluating rindopepimut in patients with newly diagnosed EGFRvIII-expressing glioblastoma (GB).
"We believe the combination of rindopepimut and Avastin in EGFRvIII-positive recurrent glioblastoma holds promise for a patient population that has very few treatment options," commented Anthony S. Marucci, President and CEO of Celldex. "Based on our exciting Phase 2 results in front-line EGFRvIII GB patients, promising data in this patient population would be very compelling in expanding treatment options for the future."
"We have experience with patients who received rindopepimut under a compassionate use program and did quite well, despite significant residual tumors, supporting the potential for a beneficial effect in patients with recurrent disease," stated Thomas Davis, M.D., Chief Medical Officer of Celldex. "Evidence of an improved response rate or delay in disease progression would provide additional support for rindopepimut approval," added Dr. Davis.
The study will enroll approximately 95 patients in a first or second relapse of glioblastoma following receipt of standard therapy and will be conducted at approximately 20 sites across the United States. Approximately 70 Avastin (bevacizumab) naive patients will be randomized to receive either rindopepimut or a control injection of Keyhole Limpet Hemocyanin (KLH) in a blinded fashion; all patients will also receive Avastin. KLH is a component of rindopepimut and was selected due to its ability to generate a similar injection site reaction to that observed with the rindopepimut vaccine.
Additionally, 25 patients refractory to Avastin®, having received Avastin in either the frontline or recurrent setting with subsequent progression, will receive rindopepimut plus Avastin in a single treatment arm. Patients in all three arms will be evaluated for the Progression Rate at six months (PFS6), objective response rate (ORR), overall survival (OS), and progression free survival (PFS).
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