About KEYTRUDA in adjuvant RCC

KEYTRUDA® (pembrolizumab) in adjuvant renal cell carcinoma (RCC)

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Expanding treatment options in RCC management for patients at increased risk of recurrence post-nephrectomy

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.1

KEYNOTE-564: a landmark study investigating the efficacy of KEYTRUDA in patients with RCC at risk of recurrence following surgery2*

The efficacy and safety of KEYTRUDA was investigated as adjuvant therapy for RCC in KEYNOTE-564, a Phase 3 landmark, multicentre, randomised, double-blind, placebo-controlled clinical study in 994 patients with intermediate-high or high risk of recurrence, or M1 NED.2

KEYNOTE-564 study design diagram

Adapted from Choueri TK et al. N Engl J Med. 2021;385(8):683–694.

*Patients at intermediate-high or high risk of recurrence of RCC.

KEYNOTE-564 baseline characteristics2*

Baseline characteristics table

*The intention-to-treat population included all the patients who underwent randomisation. Percentages may not total 100 because of rounding.2
Eastern Cooperative Oncology Group (ECOG) performance-status scores are on a scale from 0 to 5, with higher scores indicating greater disability. A score of 1 indicates that strenuous physical activity is restricted but that the patient is fully ambulatory and able to carry out light work.2
The European Union included the United Kingdom at the time of the trial.2
§Patients with M0 (no metastases) disease and an intermediate-to-high risk of recurrence had disease stages as pT2 (nuclear grade 4 tumour or sarcomatoid differentiation), N0 (no nodal involvement), M0 or as pT3 (any grade), N0, M0. Patients with M0 disease and a high risk of recurrence had disease staged as pT4 (any grade tumour), N0, M0 or as any pT (any grade tumour), N+ (involvement of nearby nodes), M0. Patients who had disease categorised as M1 (metastasis in distant organ or tissue) NED (no evidence of disease) presented not only with the primary kidney tumour but also with solid, isolated, soft-tissue metastases that were completely resected at the time of nephrectomy (synchronous) or at 1 year of less after nephrectomy (metachronous). Five patients in the M0 intermediate-to-high risk group had T2 (Grade ≤3 tumour), N0, M0 disease or T1 (tumour in kidney only of ≤7 cm in the greatest dimension), N0, M0 disease; these were protocol violations.2
The PD-L1 combined positive score was defined as the number of PD-L1-staining cells (tumour cells, lymphocytes, and macrophages) divided by the total number of viable tumour cells, multiplied by 100.2

Further resources

Who is the adjuvant RCC patient?

KEYNOTE-564: view the data


  • KEYTRUDA Summary of Product Characteristics.
  • Choueri TK et al. N Engl J Med. 2021;385(8):683–694.
  • Choueri TK et al. J Clin Oncol. 2022;40:6_suppl:290–290.
  • Choueri TK et al. N Engl J Med. 2021;385(8):683–694. Suppl.
  • Supporting documentation

    Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) 
    By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website