Annals of oncology : official journal of the European Society for Medical Oncology
August 26, 2026 · via Europe PMC
Adjuvant pembrolizumab for the treatment of clear cell renal cell carcinoma: five-year results from the phase III KEYNOTE-564 study.
Haas NB, Powles TB, Tomczak P, +15 more, Choueiri TK
AI summary — for doctors, generated from the abstract only
Five-year KEYNOTE-564 data show adjuvant pembrolizumab continues to improve disease-free and overall survival in higher-risk clear cell RCC.
What was studied
Phase 3 trial of 994 patients randomised to pembrolizumab or placebo after nephrectomy, with median follow-up of 70 months.
Key findings
- DFS HR 0.71; 5-year DFS 60.9% versus 52.2%.
- OS HR 0.66; 5-year OS 87.7% versus 82.3%.
- Safety was largely unchanged.
Clinical relevance
Reinforces adjuvant pembrolizumab as standard for high-risk ccRCC.
Who should care
Limitations
Placebo-controlled but median OS not reached, and the abstract does not detail immune toxicity.
Offer adjuvant pembrolizumab to eligible high-risk ccRCC patients.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
BACKGROUND
The randomized phase III study KEYNOTE-564 (NCT03142334) established pembrolizumab after surgery as the standard of care for patients with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence. Prior analyses showed significantly improved disease-free survival (DFS) and overall survival (OS) with adjuvant pembrolizumab versus placebo. We present results from the fourth prespecified interim analysis, with a minimum follow-up of 5 years.
PATIENTS AND METHODS
Eligible adults with ccRCC at increased risk of recurrence were randomly assigned 1 : 1 to receive adjuvant pembrolizumab 200 mg or placebo every 3 weeks following nephrectomy or following nephrectomy and metastasectomy. Study treatment continued for ≤17 cycles (∼1 year), until recurrence, or until treatment discontinuation criteria were met. The primary endpoint was DFS per investigator assessment, and the key secondary endpoint was OS. Safety was a secondary endpoint.
RESULTS
Overall, 994 participants were randomly assigned to pembrolizumab (n = 496) or placebo (n = 498). Median time from randomization to data cut-off (25 September 2024) was 70 months (range, 60-87). Pembrolizumab improved DFS versus placebo [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.59-0.86]; median DFS was not reached (NR) versus 68 months, and estimated 5-year DFS rates were 60.9% versus 52.2%, respectively. OS was improved with pembrolizumab over placebo (HR 0.66, 95% CI 0.48-0.90); median OS was NR for both arms with an estimated 5-year OS rate of 87.7% and 82.3%, respectively. DFS and OS benefits were consistent across key subgroups. Safety was largely unchanged since last analysis.
CONCLUSIONS
After a median follow-up of 70 months, adjuvant pembrolizumab demonstrated sustained DFS and OS benefit and a safety profile consistent with prior analyses. These findings continue to support the use of adjuvant pembrolizumab in ccRCC at increased risk of recurrence.
DOI
10.1016/j.annonc.2026.08.006
PMID
42648402
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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