Fotivda Alone Maintained Quality of Life in Kidney Cancer Study

Patient-reported outcomes were similar across all arms, but patients with renal cell carcinoma receiving Fotivda (tivozanib) as second-line therapy showed numerically better quality-of-life scores than those in the third-line setting following an immune checkpoint inhibitor, according to study findings presented by Dr. Katy Beckermann at the 2025 ASCO Annual Meeting.

Beckermann is the director of Genitourinary Cancer Research at Franklin Tennessee Oncology Proton Center, Medical Oncology.

In addition, Fotivda preserved FKSI-DRS and EORTC QLQ-C30 scores from baseline through week 24.

Results are based off the phase 3 TiNivo-2 study. After a median follow-up of 12 months, patients had received treatment for a median of 6.3 months with Fotivda plus Opdivo (nivolumab) and 7.4 months with Fotivda alone. More than 90% completed quality-of-life questionnaires at the start of treatment, with over 50% doing so again at week 24 (about 6 months). Compliance with both FKSI-DRS and EORTC QLQ-C30 remained above 90% at both timepoints.

The study did not meet its main goal of showing added benefit from Opdivo, but Fotivda showed meaningful results as second- and third-line treatment, according to the abstract of the study. Median progression-free survival was 5.7 months with the combination and 7.4 months with Fotivda alone, with fewer side effects in the combination group.

The FKSI‑DRS (Functional Assessment of Cancer Therapy–Kidney Symptom Index – Disease‑Related Symptoms) is a validated, nine-item questionnaire. It targets core symptoms associated with advanced kidney cancer — such as fatigue, pain, weight loss and other disease-related concerns — allowing clinicians to monitor symptom burden and gauge treatment benefit.

The EORTC QLQ‑C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30) is a 30‑question instrument widely utilized in oncology to assess overall health-related quality of life. It encompasses five functional scales (physical, role, emotional, cognitive and social), eight symptom scales (including fatigue, pain, nausea/vomiting), plus a global quality-of-life score, with responses converted to a 0 to 100 scale.

The FKSI-DRS and EORTC QLQ-C30 questionnaires were given at baseline, each treatment cycle start and end of treatment. Patients with baseline and at least one follow-up assessment were included. Descriptive statistics showed the number and percentage of patients whose quality of life improved, stayed stable or worsened.

The TiNivo-2 study compared Fotivda at 0.89 milligrams plus Opdivo versus Fotivda at 1.34 milligrams alone in patients with kidney cancer that progressed after immune checkpoint therapy.

About 326 patients were randomly assigned in equal groups to receive either Fotivda plus Opdivo or Fotivda alone. Patients in the Fotivda-only group took 1.34 milligrams daily for three weeks, followed by one week off, defining a 4-week treatment cycle. Those in the combination group took 0.89 milligrams of Fotivda daily on the same schedule, plus received Opdivo infusions at specified doses on certain days within each cycle.

Patients showing stable disease or tumor response continued treatment with both drugs until disease progression or unacceptable side effects. Opdivo was stopped after two years, but Fotivda could continue until other criteria for stopping treatment were met. Safety follow-up occurred about 30 days after the last dose.

This study included adults with advanced or metastatic clear cell renal cell carcinoma who experienced disease progression after at least six weeks of immune checkpoint inhibitor treatment in first- or second-line settings. Participants must have recovered from prior treatment side effects to grade 1 or less, have measurable disease by RECIST 1.1, an Eastern Cooperative Oncology Group performance status of 0 or 1, and follow protocol contraceptive measures.

Reference

1. “Patient-reported outcomes (PROs) for tivozanib plus nivolumab versus tivozanib monotherapy in renal cell carcinoma following immune checkpoint inhibitor: Results of the phase 3 TiNivo-2 study.” presented by Katy Beckermann, 2025 ASCO Genitourinary Cancers Symposium.

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