CheckMate 214
In previously untreated advanced RCC, does nivolumab plus ipilimumab improve survival compared with sunitinib?
Absolute Effect
Intermediate/poor-risk patients; HR for death 0.63 in the primary analysis.
Long-term follow-up showed durable survival separation.
Response and toxicity
At 42 months, ORR in intermediate/poor-risk disease was 42.1% versus 26.3%. Grade 3–4 treatment-related events occurred in 46% versus 63%; treatment-related adverse events leading to discontinuation occurred in 22% versus 12%.
Clinical interpretation
Favorable-risk patients were exploratory and did not show the same efficacy pattern; they should not be conflated with the primary population.
NNT / NNH
Using the 18-month OS difference, NNT ≈ 7. For grade 3–4 treatment-related adverse events, the absolute reduction was 17 points, corresponding to an approximate NNT of 6 to avoid one such event versus sunitinib; toxicity profiles are qualitatively different, so this is not a complete harm comparison.
Treatment-free time
At 42 months, 18% of intermediate/poor-risk patients receiving nivolumab/ipilimumab were alive and treatment-free versus 5% with sunitinib; mean treatment-free survival was 6.9 versus 3.1 months.
Primary / authoritative sources
Current-practice context · reviewed 14 October 2026
Nivolumab/ipilimumab remains an established first-line option for advanced clear-cell RCC, particularly in IMDC intermediate/poor-risk disease. Its durable responses and treatment-free intervals should be balanced against immune-mediated toxicity and the possibility of early progression. Do not extrapolate the primary intermediate/poor-risk result to favorable-risk patients.
Compare with contemporary IO–TKI options using patient factors and current local guidance; cross-trial comparisons are not randomized head-to-head evidence.
EAU RCC disease-management guidance ↗
Targeted freshness note added 14 October 2026; exhaustive guideline reconciliation remains pending.