The phase 3 TiNivo-2 study found that combining Fotivda (tivozanib) with Opdivo (nivolumab) resulted in patient-reported outcomes (PROs) similar to those of treatment with Fotivda alone in patients with locally advanced or metastatic clear cell renal cell carcinoma (RCC) whose disease progressed after one or two systemic therapies, including at least one immune checkpoint inhibitor, according to data shared at the 2025 Genitourinary Cancers Symposium.
Glossary:
Patient-reported outcomes: reports on a patient’s health condition that come directly from the patient themselves.
Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Disease-Related Symptoms (FKSI-DRS): a tool used to measure the severity of symptoms specifically related to kidney cancer in patients.
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires: an assessment that measures quality of life in patients with cancer.
Progression-free survival: The time a patient lives without their disease spreading or worsening.
PRO data showed that Fotivda maintained stable mean scores on the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires. The trial enrolled patients with radiographic progression during or after at least six weeks of ICI treatment in the first or second line, who had recovered from prior treatment-related side effects to grade 1 or baseline, had confirmed clear cell RCC and measurable disease.
In an interview with CURE®, Dr. Katy Beckermann sat down to discuss the trial. She specifically went over how the combination of Fotivda and Opdivo compare with Fotivda alone based on patient feedback from the TiNivo-2 study.
Beckermann is the medical director of Genitourinary Clinical Research, Medical Oncology, and a clinician scientist at the Tennessee Oncology Proton Center, in Franklin.
Transcript:
I think that this study allowed us to look at Fotivda in a setting where it hasn't previously been studied. Fotivda — prior to the study — we had data for it in a more refractory patient population. [Investigators] are looking at patients who are in the third- and fourth-line treatment setting. What I think TiNivo-2 study did is, first of all, it told us we should not continue immuno-oncology therapy in a refractory setting.
It also then gave us some insight for how Fotivda would both perform from an efficacy standpoint. [For example], we saw the progression-free survival being better in patients who were in the second-line as compared with those in the third-line, and that it supported a maintenance of quality of life. I think that was helpful information.
Transcript has been edited for clarity and conciseness.
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