PROs Similar With Tivozanib Monotherapy vs Combination in RCC

Patient-reported outcomes (PROs) were similar among those treated with tivozanib monotherapy and those given combination tivozanib and nivolumab for renal cell carcinoma (RCC) in the TiNivo-2 study (NCT04987203), according to a poster presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held February 13-15, 2025, in San Francisco, California.

Study author Katy Beckermann, MD, PhD, assistant professor of medicine, Vanderbilt University Medical Center, and medical director of genitourinary clinical research, Tennessee Oncology, discussed how PROs were measured in the study and what the findings were.

This transcript has been lightly edited; captions are auto-generated.

Transcript

How was patient-reported quality of life evaluation here, and what were the completion and compliance rates?

I think it's a really important question that we should obviously take into account. How are patients' quality of life in the in the refractory space if we're essentially dose intensifying or if we're adding treatment regimens, is that going to add any toxicity, and does that affect quality of life? And so this was an exploratory end point on the clinical trial using 2 different metrics: the EORTC [European Organisation for Research and Treatment of Cancer] questionnaire and the FKSI [Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index] questionnaire. You'll see across the treatment arms, it was taken at baseline and at day 1 of every single cycle, and the completion rate was equivalent amongst the arms. And so from that then we tried to assess, what were the quality of life metrics? And tivozanib kept these QOL [quality of life] measures even from beginning to the end of study, both based on FKSI and the EORTC studies.

Although adding nivolumab to tivozanib didn't provide any additional benefit vs tivozanib alone, what are the benefits to being able to justify using a monotherapy vs a combination therapy for patient satisfaction and quality of life?

Well, I think from this clinical trial, because it was a negative clinical trial, we would not ever recommend the combination treatment based on efficacy. And then certainly, based on TiNivo-2, based on TIVO-3, tivozanib is certainly an FDA-approved, NCCN [National Comprehensive Cancer Network]–recommended option in the treatment for patients with refractory kidney cancer.