Tivozanib: Additional Phase III data

Additional data from the open-label, international Phase III TIVO-1 trial in 517 patients showed that once-daily 1.5 mg oral tivozanib met the secondary endpoint of improving ORR vs. sorafenib (33% vs. 23%, p=0.014). In a subgroup of patients who had previously received systemic therapy, tivozanib led to a median PFS of 11.9 months vs. 9.1 months for sorafenib. OS data, which are not yet mature, are expected in 2013. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. In January, Aveo reported that tivozanib met the primary endpoint of median PFS vs. sorafenib (11.9 vs. 9.1 months, p=0.042). In a subgroup of patients who received no prior systemic anti-cancer therapy, tivozanib also significantly improved median PFS vs. sorafenib (12.7 vs. 9.1 months, p=0.037) (see BioCentury, Jan. 9). ...