Study Shows No Benefit to Pairing Fotivda With Opdivo for RCC

AVEO Oncology announced that adding its renal cell carcinoma (RCC) therapy Fotivda (tivozanib) to treatment with Bristol Myers Squibb’s Opdivo (nivolumab) did not demonstrate a benefit for patients in a phase 3 trial.

The TiNivo-2 study paired low-dose Fotivda with Opdivo in individuals whose tumors had progressed following immune checkpoint inhibitor therapy. Those results were compared with Fotivda alone as the control arm. However, the combination of drugs failed to meet the primary end point of improving progression-free survival. 

Fotivda is an oral vascular endothelial growth factor tyrosine kinase inhibitor. The US Food and Drug Administration approved it in 2021 for use as monotherapy for adults with relapsed or refractory advanced RCC after at least two prior systemic therapies. After the disappointing combination therapy results, AVEO pointed out that the control arm data supported the continued use of Fotivda as monotherapy.