Galena Biopharma, a biotechnology company focused on developing targeted oncology treatments, has initiated its phase III PRESENT trial for NeuVax (E75 peptide plus GM-CSF) vaccine in HER2 1+ and 2+ breast cancer patients (often referred to as HER2 negative) in the adjuvant setting to prevent recurrence.
"Approximately 50% of breast cancer patients have tumors that are HER2 1+ or 2+. These patients are successfully rendered disease-free following treatment with current standards of care, and then are sent home to watch and wait with the hope their cancer never returns,” said Beth Mittendorf, M.D., principal investigator for the PRESENT phase III study. “Our encouraging findings from the previous phase I/II clinical trial show that NeuVax may provide a significant benefit to maintain disease-free survival in these patients who have no other [adjuvant therapy/treatment] options.”
The NeuVax phase III multinational trial will be conducted in approximately 700 adjuvant breast cancer patients who are node positive, have an HLA status of A2/A3+, and have low or intermediate HER2 expression (IHC 1+, 2+, sometimes referred to as HER2 negative). These patients are not eligible to receive Herceptin (trastuzumab, marketed by Roche-Genentech) therapy that is currently approved only for patients with high HER2, or 3+ expression.
Once qualified patients have achieved a complete response from current standard-of-care treatment (surgery, radiation and/or chemotherapy), they will be randomized and dosed with either NeuVax or a placebo plus GM-CSF. Patients will receive one intradermal injection every month for six months, followed by a booster inoculation every six months thereafter. The primary endpoint is disease-free survival at three years or 139 events (recurrence of cancer). A data safety monitoring board will conduct an interim analysis for safety and futility after 70 events.
Galena is currently on track for the initiation of approximately 100 investigative sites in the U.S. and abroad.