Trial finds no benefit of adding nivolumab to tivozanib for advanced kidney cancer

Dana-Farber Cancer InstituteSep 13 2024

Study title: Tivozanib Plus Nivolumab vs Tivozanib Monotherapy in Patients with Renal Cell Carcinoma Following an Immune Checkpoint Inhibitor – Results of the Phase 3 TiNivo-2 Study

Publication: The Lancet and European Society for Medical Oncology 2024 Abstract LBA 73

Dana-Farber Cancer Institute authors: Toni K. Choueiri, MD, Bradley McGregor, MD

Summary: In an international multicenter randomized phase 3 clinical trial led by Dana-Farber Cancer Institute, researchers tested the addition of the immune checkpoint inhibitor (ICI) nivolumab to treatment with tivozanib for patients with advanced clear cell renal cell carcinoma, a form of kidney cancer. Tivozanib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, has antiangiogenic effects and is thought to be synergistic with an ICI. Eligible patients had received one or two prior lines of therapy, including an ICI. The addition of nivolumab, a PD-1 inhibitor, to tivozanib did not delay the progression of cancer, nor improve overall survival or response rates compared to tivozanib monotherapy according to the team's analysis. This was true whether the patient received an ICI in their most recent prior therapy or earlier.

Significance: Immune checkpoint inhibitors such as those that block PD-1 and PD-L1 have revolutionized cancer therapy and become part of standard first-line therapy for many solid tumors, including for advanced kidney cancer. Questions remain about how best to sequence treatment with an ICI after progression on prior ICI. This study is only the second to ask such a question. Repeat ICI therapy should be discouraged in patients with advanced renal cell carcinoma.

Funding: Aveo Pharmaceuticals, Inc.