The Absolute Effect / Evidence / KEYNOTE-564
Renal Cell Carcinoma · Medical Oncology · Adjuvant
KEYNOTE-564
Clinical question
Does adjuvant pembrolizumab improve disease-free and overall survival after nephrectomy for high-risk clear-cell RCC?
Trial context
Population
994 patients with high-risk clear-cell RCC after nephrectomy, with or without completely resected metastases
Intervention
Adjuvant pembrolizumab 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 77.3% with pembrolizumab versus 68.1% with placebo, an absolute benefit of 9.2 percentage points (NNT 11). Overall survival at 24 months was 96.6% vs 93.5%. Grade 3+ adverse events were 32.4% vs 17.7%.
NNT: 11
Treatment burden / harm
Grade 3+ adverse events
NNH: 7
Relative effect
HR: 0.68
95% CI 0.53–0.87; P=.002
Clinical interpretation
Adjuvant pembrolizumab improves disease-free and overall survival in eligible high-risk RCC after nephrectomy, but immune toxicity and recurrence-risk selection are central to the decision.
Primary publication
- Choueiri TK, et al. N Engl J Med. 2021;385:683–694.
- Powles T, et al. N Engl J Med. 2024;390:1359–1371.
- Primary publication / source
- Primary publication / source