Tivozanib is a drug that blocks the blood supply to tumours (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, TKI), and has been shown to be effective and safe in patients with advanced renal cell carcinoma (RCC) when used alone. This study reports the final results from phase 1b/2 clinical trial of tivozanib combined with nivolumab, an immune checkpoint inhibitor that stimulates the immune system to attack cancer cells.
Twenty five (25) patients were treated in the study. Twelve (12) were previously untreated, while 13 had already received drug treatment. Overall response rate was 56% and there was one complete response. Disease control rate was 96% and twenty patients (80%) had shrinkage of their tumour. Time to best response was around 7.9 weeks. Average progression-free survival was 18.9 months in all patients and was similar in untreated and previously treated patients.
Twenty patients (80%) reported severe or life-threatening adverse events, eight patients stopped treatment because of adverse events, and four patients (17%) had a reduction in dose because of adverse events.
The tivozanib plus nivolumab combination was generally well tolerated and had a promising effect on the tumour. Further studies are needed to confirm this combination as a treatment for untreated/previously treatment metastatic RCC patients.