Fotivda preserved quality-of-life scores in kidney most cancers, with higher outcomes in second-line use and no additional benefit from combining with Opdivo.
Affected person-reported outcomes have been comparable throughout all arms, however sufferers with renal cell carcinoma receiving Fotivda (tivozanib) as second-line remedy confirmed numerically higher quality-of-life scores than these within the third-line setting following an immune checkpoint inhibitor, in keeping with research findings offered by Dr. Katy Beckermann on the 2025 ASCO Annual Assembly.
Beckermann is the director of Genitourinary Most cancers Analysis at Franklin Tennessee Oncology Proton Heart, Medical Oncology.
As well as, Fotivda preserved FKSI-DRS and EORTC QLQ-C30 scores from baseline by week 24.
Outcomes are based mostly off the section 3 TiNivo-2 research. After a median follow-up of 12 months, sufferers had obtained remedy for a median of 6.3 months with Fotivda plus Opdivo (nivolumab) and seven.4 months with Fotivda alone. Greater than 90% accomplished quality-of-life questionnaires in the beginning of remedy, with over 50% doing so once more at week 24 (about 6 months). Compliance with each FKSI-DRS and EORTC QLQ-C30 remained above 90% at each timepoints.
The research didn’t meet its important purpose of exhibiting additional benefit from Opdivo, however Fotivda confirmed significant outcomes as second- and third-line remedy, in keeping with the summary of the research. Median progression-free survival was 5.7 months with the mixture and seven.4 months with Fotivda alone, with fewer unwanted side effects within the mixture group.
The FKSI‑DRS (Useful Evaluation of Most cancers Remedy–Kidney Symptom Index – Illness‑Associated Signs) is a validated, nine-item questionnaire. It targets core signs related to superior kidney most cancers — akin to fatigue, ache, weight reduction and different disease-related issues — permitting clinicians to watch symptom burden and gauge remedy profit.
The EORTC QLQ‑C30 (European Organisation for Analysis and Therapy of Most cancers High quality of Life Questionnaire–Core 30) is a 30‑query instrument broadly utilized in oncology to evaluate total health-related high quality of life. It encompasses 5 useful scales (bodily, function, emotional, cognitive and social), eight symptom scales (together with fatigue, ache, nausea/vomiting), plus a world quality-of-life rating, with responses transformed to a 0 to 100 scale.
The FKSI-DRS and EORTC QLQ-C30 questionnaires got at baseline, every remedy cycle begin and finish of remedy. Sufferers with baseline and no less than one follow-up evaluation have been included. Descriptive statistics confirmed the quantity and proportion of sufferers whose high quality of life improved, stayed secure or worsened.
The TiNivo-2 research in contrast Fotivda at 0.89 milligrams plus Opdivo versus Fotivda at 1.34 milligrams alone in sufferers with kidney most cancers that progressed after immune checkpoint remedy.
About 326 sufferers have been randomly assigned in equal teams to obtain both Fotivda plus Opdivo or Fotivda alone. Sufferers within the Fotivda-only group took 1.34 milligrams day by day for 3 weeks, adopted by one week off, defining a 4-week remedy cycle. These within the mixture group took 0.89 milligrams of Fotivda day by day on the identical schedule, plus obtained Opdivo infusions at specified doses on sure days inside every cycle.
Sufferers exhibiting secure illness or tumor response continued remedy with each medication till illness development or unacceptable unwanted side effects. Opdivo was stopped after two years, however Fotivda might proceed till different standards for stopping remedy have been met. Security follow-up occurred about 30 days after the final dose.
This research included adults with superior or metastatic clear cell renal cell carcinoma who skilled illness development after no less than six weeks of immune checkpoint inhibitor remedy in first- or second-line settings. Contributors will need to have recovered from prior remedy unwanted side effects to grade 1 or much less, have measurable illness by RECIST 1.1, an Japanese Cooperative Oncology Group efficiency standing of 0 or 1, and comply with protocol contraceptive measures.
Reference
- “Affected person-reported outcomes (PROs) for tivozanib plus nivolumab versus tivozanib monotherapy in renal cell carcinoma following immune checkpoint inhibitor: Outcomes of the section 3 TiNivo-2 research.” offered by Katy Beckermann, 2025 ASCO Genitourinary Cancers Symposium.
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