The KEYNOTE-564 trial showed that adjuvant immune checkpoint inhibitor (ICI) therapy with pembrolizumab, a PD-1 antibody, significantly improved disease-free survival (DFS) and overall (OS) survival in localised clear-cell renal cell carcinoma (RCC) with a high risk of relapse. The TiNivo and CONTACT-03 trials have reported results for subsequent therapy after progression on ICI therapy in the metastatic setting. The European Association of Urology (EAU) RCC guidelines panel reassessed the new trial results to update recommendations for adjuvant therapy and post-adjuvant therapy. Adjuvant pembrolizumab significantly improved OS (hazard ratio 0.62, 95% confidence interval 0.44-0.87; p = 0.005). Recent trials of subsequent ICI after recurrence on ICI in the metastatic setting do not support ICI monotherapy or combination therapy in patients with recurrence on or after adjuvant ICI therapy. There are no prospective trial results for treatment after adjuvant pembrolizumab failure. On the basis of the recent results, the EAU RCC guidelines panel has updated the recommendation for adjuvant therapy and now issues a strong recommendation for adjuvant pembrolizumab. ICI monotherapy or combination therapy is not recommended in patients with recurrence during or shortly after adjuvant pembrolizumab. PATIENT SUMMARY: Treatment with an immunotherapy drug called pembrolizumab after surgery in patients with intermediate-risk or high-risk kidney cancer delays the time to recurrence of cancer and prolongs survival. Therefore, pembrolizumab after surgery is strongly recommended for these patients. However, a significant proportion of patients have life-changing or serious side effects and these must be discussed.

Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet Stockholm Sweden

Department of Cancer Medicine Gustave Roussy Université Paris Saclay Villejuif France

Department of Translational Medicine Division of Urological Cancers Lund University Malmö Sweden

Department of Translational Medicine University of Eastern Piedmont Maggiore Della Carità Hospital Novara Italy

Department of Urology Addenbrookes Hospital Cambridge UK

Department of Urology and Transplantation Surgery and Eva Mayr Stihl Cancer Center Klinikum Stuttgart Stuttgart Germany

Department of Urology Chaim Sheba Medical Center Tel Hashomer Ramat Gan Israel

Department of Urology Charité Universitätsmedizin Berlin Berlin Germany

Department of Urology Coimbra University Hospital Coimbra Portugal

Department of Urology Institut Paoli Calmettes Marseille France

Department of Urology San Raffaele Scientific Institute Milan Italy; Division of Experimental Oncology Unit of Urology Urological Research Institute IRCCS San Raffaele Hospital Milan Italy

Department of Urology University Hospital Pilsen and Faculty of Medicine in Pilsen Charles University Pilsen Czechia

Department of Urology University of Eastern Piedmont Maggiore della Carità Hospital Novara Italy

Division of Surgery and Interventional Sciences University College London London UK; Specialist Centre for Kidney Cancer Royal Free Hospital London UK

Division of Surgery and Interventional Sciences University College London London UK; Specialist Centre for Kidney Cancer Royal Free Hospital London UK; The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital Amsterdam The Netherlands

Karolinska University Hospital Stockholm Sweden; Division of Cardiology Department of Medicine Karolinska Institutet Stockholm Sweden

Royal Free London NHS Trust and Barts Cancer Institute Queen Mary University of London London UK

Unit of Urological Robotic Surgery and Renal Transplantation University of Florence Careggi Hospital Florence Italy; Department of Experimental and Clinical Medicine University of Florence Florence Italy; European Association of Urology Young Academic Urologists Renal Cancer Working Group Arnhem The Netherlands

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