Galena Biopharma Inc. (GALE) initiated its Phase 3 PRESENT trial for NeuVax vaccine in HER2 1+ and 2+ breast cancer patients, often called as HER2 negative, in the adjuvant setting to prevent recurrence. The NeuVax Phase 3 trial would be conducted in adjuvant breast cancer patients who are node positive, have an HLA status of A2/A3+, and have low or intermediate HER2 expression. These patients are not eligible to receive Herceptin therapy that is currently approved only for patients with high HER2, or 3+ expression.
The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment or PRESENT study is a randomized, multicenter, multinational clinical trial that would enroll around 700 breast cancer patients. The FDA has agreed that the design and planned analysis of the Phase 3 study adequately address the objectives necessary to support an acceptable regulatory submission for marketing approval.
The primary endpoint is disease-free survival at three years or 139 events. A data safety monitoring board would conduct an interim analysis for safety and futility after 70 events. Currently, Galena is on track for the initiation of about 100 investigator sites in the U.S. and abroad.
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