During the 16th European Multidisciplinary Congress on Urological Cancers (EMUC24), Jens Bedke, MD, presented updated results from the KEYNOTE-564 trial, which evaluated the efficacy of adjuvant pembrolizumab in patients with clear cell renal cell carcinoma (ccRCC). The trial demonstrated a continued survival benefit for patients receiving pembrolizumab, with significant improvements in disease-free survival (DFS) and overall survival (OS) compared to placebo.
Key findings include a 38% reduction in the risk of death with adjuvant pembrolizumab and survival benefits across key subgroups. The study also noted a 28% reduction in the risk of death in the intention-to-treat population, with stable improvement curves and no new safety signals observed during further follow-up.
Bedke highlighted the importance of prognostic markers, such as KIM-1, which was associated with worse DFS in the IMmotion010 trial. High levels of KIM-1 at baseline were predictive for adjuvant atezolizumab, suggesting its potential as a biomarker for treatment response.
The KEYNOTE-564 trial enrolled 994 patients, randomly assigning them to receive either pembrolizumab or placebo every 3 weeks for about 1 year. The primary endpoint was DFS, with secondary endpoints including OS and safety. The trial showed a DFS of 78.3% in the pembrolizumab group versus 67.3% in the placebo group at the updated analysis.
In conclusion, pembrolizumab represents the first adjuvant treatment in RCC to show an improved overall survival, as observed in the KEYNOTE-564 trial. The exploration of biomarkers like KIM-1 offers promising avenues for predicting treatment outcomes and tailoring therapy for patients with ccRCC.
