AVEO Oncology has announced a Phase III flop of its advanced metastatic renal cell carcinoma (RCC) combination therapy but has scored another win for its lead drug Fotivda as a monotherapy.
The company, which is part of the LG Chem group, said the TiNivo-2 trial (NCT04987203) had not met the primary endpoint of progression-free survival (PFS).
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The trial was evaluating a combination of Opdivo (nivolumab) and low-dose Fotivda (tivozanib) in patients with advanced metastatic renal cell carcinoma (RCC) whose tumours had progressed following prior immune checkpoint inhibitor (ICI) treatment.
Despite the failure in the combination arm, the control arm using Fotivda alone at standard dose demonstrated a clinically meaningful outcome in median PFS in the second line following ICI combination therapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor while the chemotherapy regimen comprised mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab.
Fotivda is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
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By GlobalDataAVEO Oncology says this new data supports data from the TIVO-3 trial (NCT02627963), FOTIVDA’s pivotal study, which met the primary endpoint of PFS.
This further supports the use of Fotivda in relapsed or refractory advanced RCC as a third-line therapy.
AVEO Oncology chief executive officer and president Michael Bailey said: “The PFS and safety of the FOTIVDA control arm in the second-line following ICI combinations adds to the growing body of evidence of the importance of a highly selective anti-VEGFR TKI therapy as an effective, well-tolerated treatment option for relapsed or refractory RCC patients treated with prior ICI combination therapy.
“While the addition of an ICI to low dose Fotivda did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations.”
More data, including the evaluation of secondary endpoints, including overall survival, will be presented at a later date.
LG Chem acquired AVEO Oncology in 2022 for $566m, one year after the company gained approval for Fotivda. EUSA Pharma licensed Fotivda from AVEO Oncology in 2015 during the development process.
