- AVEO Oncology's (NASDAQ:AVEO) slog to prove a treatment effect from tivozanib in colorectal cancer continues. The company recently presented the results from a Phase 2 trial to the FDA, called BATON-CRC, that failed to demonstrate a statistically significant treatment advantage from tivozanib + mFOLFOX6 (chemo regimen) compared to bevacizumab (Roche's Avastin) + mFOLFOX6 in patients with NRP-1 low colorectal cancer (CRC). Median progression-free survival (PFS), the primary endpoint, was 167 days in the tivozanib arm compared to 162 days in the bevacizumab arm.
- Among the predictive biomarkers explored in BATON-CRC was neuropilin-1 (NRP-1), a signaling protein known to bind to VEGF-A in serum. Bevacizumab is a monoclonal antibody that binds to (inhibits) VEGF-A (vascular endothelial growth factor A) while tivozanib binds to all three VEGF receptors. AVEO believes that NRP-1 could be predictive of tivozanib activity versus bevacizumab.
- The FDA stated that there is not enough data to prove NRP-1's predictive value. AVEO will, therefore, have to conduct another randomized Phase 2 study to show a superior treatment effect of tivozanib versus bevacizumab before advancing to Phase 3. Concurrently, it will continue its efforts to develop a commercially viable companion diagnostic.
- Tivozanib is faring much better in kidney cancer. A Phase 3 study, TIVO-1, successfully achieved its efficacy endpoints.
- Previously: Aveo up on positive tivozanib data; shares up 17% premarket (June 2)