AVEO Oncology kidney cancer combo did not meet endpoints in Phase III

AVEO Oncology has reported mixed results from its recent trials. The Phase III TiNivo-2 trial (NCT04987203) did not achieve its primary endpoint of progression-free survival (PFS) for the combination therapy of Opdivo (nivolumab) and low-dose Fotivda (tivozanib) in advanced metastatic renal cell carcinoma (RCC) patients. The study focused on those whose tumors had progressed after previous immune checkpoint inhibitor (ICI) treatment.

However, Fotivda alone, at a standard dose, showed a significant improvement in median PFS in the second line following ICI therapy. This supports the findings of the TIVO-3 trial (NCT02627963), which demonstrated Fotivda’s efficacy as a third-line treatment for relapsed or refractory advanced RCC.

AVEO’s results underscore the role of Fotivda as a selective anti-VEGFR TKI therapy. Further data, including overall survival, will be released later. LG Chem acquired AVEO for $566 million in 2022.