Nivolumab does not improve survival in patients with advanced renal cell carcinoma with progression after immune checkpoint inhibitors

1. No significant difference was seen regarding progression-free survival between the tivozanib-nivolumab and tivozanib monotherapy groups.

2. Serious adverse events were comparable between both intervention groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitors are crucial in the first-line treatment of advanced renal cell carcinoma. Despite this, treatment following disease progression on first-line medication remains unclear. This randomized controlled trial aimed to compare the efficacy of tivozanib–nivolumab combination therapy with tivozanib monotherapy in patients with advanced renal cell carcinoma who had progressed after ICI therapy. The primary outcome was progression-free survival (PFS), while a key secondary outcome was safety, measured by the occurrence of serious adverse events. According to study results, there was no significant difference in median PFS between groups. Although this study was well done, it was limited by a relatively short follow-up period of 12 months, which may not capture long-term outcomes.

Click to read the study in The Lancet

Relevant Reading: Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study

In-depth [randomized-controlled trial]: Between Nov 4, 2021, and Jun 16, 2023, 429 patients were screened for eligibility from 190 sites across 16 countries. Included were patients with advanced renal cell carcinoma who had progressed following ICI therapy. Altogether, 343 patients (171 in tivozanib-nivolumab and 172 in tivozanib monotherapy) were included in the final analysis. The primary outcome of PFS was slightly lower in the tivozanib-nivolumab group compared to tivozanib monotherapy (5.7 months vs. 7.4 months, hazard ratio [HR] 1.10, 95% confidence interval [CI] 0.84-1.43, p=0.49). The secondary outcome of safety revealed a similar rate of serious adverse events in both groups (32% vs. 37%). Findings from this study suggest that nivolumab-tivozanib combination therapy does not provide additional survival benefits compared to tivozanib monotherapy in patients who demonstrated disease progression post-ICI.

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