The Absolute Effect / Evidence / CheckMate 914
Renal Cell Carcinoma · Medical Oncology · Adjuvant
CheckMate 914
Clinical question
Does adjuvant nivolumab plus ipilimumab improve disease-free survival after nephrectomy for high-risk RCC?
Trial context
Population
816 patients with localized RCC at high risk of recurrence after nephrectomy
Intervention
Adjuvant nivolumab + ipilimumab vs placebo after nephrectomy
Key endpoint
24-month disease-free survival
Time horizon / follow-up
24 months
Absolute Effect
What changes for patients?
At 24 months, disease-free survival was 76% with nivolumab plus ipilimumab versus 74% with placebo, an absolute difference of only 2 percentage points (NNT 50). The primary DFS endpoint was not met. Grade 3–5 adverse events were 38% vs 10%, and treatment discontinuation was 32% vs 2%.
NNT: 50
Treatment burden / harm
Grade 3–5 adverse events
NNH: 4
Relative effect
HR: 0.92
95% CI 0.71–1.19; P=.53
Clinical interpretation
The negative primary endpoint and added immune toxicity argue against adjuvant nivolumab plus ipilimumab after nephrectomy as a routine RCC strategy.
Primary publication
- Motzer RJ, et al. Lancet. 2023;401:821–832.
- Primary publication / source