Why European Experts Cautiously Recommend Pembrolizumab to Treat High-Risk Kidney Cancer Following Surgery

Despite the observed disease-free survival benefit associated with pembrolizumab in high-risk kidney cancer after surgery, the European Association of Urology guidelines maintain a weak recommendation for its use.

Although pembrolizumab (Keytruda) yielded a statistically significant benefit in terms of disease-free survival (DFS) in patients with high-risk renal cell carcinoma after surgery, a panel of experts cautiously recommend its use as an adjuvant therapy.

Axel Bex, MD, PhD, a urologic surgeon at the Specialist Centre For Kidney Cancer, Royal Free London NHS Foundation Trust, and a professor at University College London, Division of Surgery and Interventional Science, spoke with CancerNetwork® during the 2022 Society for Urologic Oncology (SUO) Annual Meeting about the updated efficacy findings from the KEYNOTE-564 trial and why the European Association of Urology (EAU) gave pembrolizumab a weak recommendation.1

In the KEYNOTE-564 trial, the DFS benefit of pembrolizumab was indicated with a hazard ratio of 0.63 (95% CI, 0.50-0.80; P < .0001).

However, given the negative findings of other kidney cancer trials investigating immune checkpoint inhibitors, the EAU updated guidelines in October 2022 reaffirming a weak recommendation for offering adjuvant pembrolizumab to patients with clear cell renal cell carcinoma.2 Additionally, authors of the guidelines, including Bex, recommended robust discussion with patients about results from other clinical trials and the potential for overtreatment when offering pembrolizumab as therapy to patients.


We had 1 positive trial, which was KEYNOTE-564, which was investigating pembrolizumab. We had a recent update in which the hazard ratio was 0.63, which is statistically significant for disease-free survival, which also means it's a reduction of 37% in the risk of progressing and recurring or dying from a disease, which is very a positive result. The reason why we decided to take this weak recommendation [from the EAU panel] is because there's an early overall survival signal, which is not yet statistically significant but may turn out to be statistically significant.


  1. Choueiri TK, Tomczak P, Park SH, et al. Pembrolizumab as post nephrectomy adjuvant therapy for patients with renal cell carcinoma: Results from 30-month follow-up of KEYNOTE-564. J Clin Oncol. Published online February 16, 2022. doi:10.1200/JCO.2022.40.6
  2. Bedke J, Albiges L, Capitanio U, et al. The 2022 Updated European Association of Urology Guidelines on the use of adjuvant immune checkpoint inhibitor therapy for renal cell carcinoma. European Urology. 2022;83(1):10-14. doi:10.1016/j.eururo.2022.10.010
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