Aveo Pharmaceuticals presents TIVO-3 trial topline results

Aveo Oncology announced the presentation of data from the Phase 3 TIVO-3 study of tivozanib versus sorafenib in refractory advanced or metastatic renal cell carcinoma. The data were presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium held February 14-16, 2019 in San Francisco. The TIVO-3 trial is a Phase 3 randomized, controlled, multi-center, open-label study designed to compare tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic renal cell carcinoma. The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival. Tivozanib demonstrated a 44% improvement in median PFS and 26% reduction in the risk of progression or death. Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib. The TIVO-3 trial enrolled patients with RCC who have failed at least two prior regimens. Among these, approximately 26% of patients received checkpoint inhibitor therapy in earlier lines of treatment. PFS for tivozanib was longer than sorafenib both in patients who received prior CPI therapy and those who received two prior VEGF TKI therapies. Patients who received prior CPI therapy had a median PFS of 7.3 months with tivozanib and 5.1 months with sorafenib. One- and two-year PFS in patients who received tivozanib following CPI therapy was 35% and 25%, respectively, and 4% and n/a for patients receiving sorafenib following CPI therapy at those respective time periods. The secondary endpoint of overall response rate for patients receiving tivozanib was 18% compared to 8% for patients receiving sorafenib. Median duration of response in patients receiving tivozanib was not reached and was 5.7 months for patients receiving sorafenib. DOR probability at 1 year was 71% and 46% for tivozanib and sorafenib, respectively, and 55% and 0% at two years. The analysis of the secondary endpoint of overall survival was not mature at the time of the final PFS analysis, and currently reflects about 50% of potential OS events. As previously disclosed, the updated preliminary OS analysis conducted at an October 4, 2018 data cutoff date, which included additional patients previously lost to follow-up, showed a non-statistically significant difference in OS favoring sorafenib. The company intends to conduct an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

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