- AVEO Oncology (NASDAQ:AVEO +5.4%) is up on 30% higher volume in response to positive results from the Phase 1b portion of a Phase 1b/2 clinical trial assessing lead drug FOTIVDA (tivozanib) in patients with advanced unresectable hepatocellular carcinoma (HCC). The data were presented at the ASCO-GI Symposium in San Francisco.
- Median progression-free survival (PFS) in 19 evaluable patients at week 24 was 5.5 months and 47% (n=9/19) had stable disease. The disease control rate (responders + those with stable cancer) was 63% (n=12/19), including four partial responders and eight with stable disease. Four subjects remained progression-free for over two years. Overall survival (OS) at month 6 and month 12 was 58% and 25%, respectively.
- On the safety front, two patients experienced dose-limiting toxicities (Grade 3 mucositis and hypertension) upon receiving the 1.5 mg dose (highest) and withdrew from the study.
- The 1.0 mg dose will be evaluated in the Phase 2 portion.
- Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is designed to optimize VEGF blockade while minimizing toxic side effects.