- Nivolumab in the long term significantly improved OS in previously treated patients with clear cell advanced renal cell carcinoma (RCC) vs everolimus.
Why this matters
- Findings confirm long-term OS benefit of nivolumab in this setting.
- Phase 3 CheckMate 025 trial of 803 previously treated patients with clear cell advanced RCC, randomly assigned to nivolumab or everolimus.
- Funding: Bristol-Myers Squibb Company; ONO Pharmaceutical Company, Ltd.
- Median follow-up was 72 months.
- OS was significantly longer in the nivolumab group (HR, 0.73; P<.0001>
- 5-year OS probability was 26% with nivolumab and 18% with everolimus.
- PFS was significantly improved with nivolumab (HR, 0.84; P=.0331).
- In nivolumab vs everolimus groups:
- Objective response rate was 22.9% vs 4.1% (OR, 6.86; P<.0001>
- Median time to response was 3.5 vs 3.7 months.
- Median duration of response was 18.2 vs 14.0 months.
- Any grade: 80.5% vs 88.9%.
- Grade 3/4: 21.4% vs 36.8%.
- Fatigue was the most common adverse event (34.7% vs 34.5%).
- Open label.