KEYNOTE-564 trial: KEYTRUDA® (pembrolizumab) Improves Overall Survival in Renal Cell Carcinoma Patients Post-Nephrectomy

By: Dr. Anish Shah 

Bronx-Lebanon Hospital; Bronx, NY



Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), significantly improves overall survival (OS) in renal cell carcinoma (RCC) patients at a higher risk of recurrence post- nephrectomy, according to results from the Phase 3 KEYNOTE-564 trial. This marked the first time a therapy had demonstrated a statistically significant survival benefit compared to a placebo in this patient population.


The KEYNOTE-564 trial is a randomized, double-blind Phase 3 trial evaluating KEYTRUDA for the adjuvant treatment of patients with RCC who have undergone nephrectomy and are at intermediate-high risk, high risk, or M1 no evidence of disease. The trial enrolled 994 patients who were randomized to receive either KEYTRUDA or placebo. In an earlier interim analysis with a median follow-up of 23.9 months, KEYNOTE-564 met its primary endpoint of disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo. These DFS results were first presented at the 2021 American Society of Clinical Oncology Annual Meeting and supported the approvals of KEYTRUDA for the adjuvant treatment of patients with RCC worldwide.


The results were later published in New England Journal of Medicine under the title of “Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma” in August of 2021 while the therapy was granted approval for the indication in November of the same year. The first author of the study, Dr. Choueiri – Chief of GU Cancers at DanaFarber, tweeted enthusiastically while sharing the published article “On the heels of @ASCO #ASCO2021 plenary, we are happy to share the results of KEYNOTE-564 trial of adjuvant pembrolizumab in mRCC just published in @NEJM ! A step towards better outcomes in all our patients with kidney cancer!“. Dr Neeraj Agarwal from Huntsman Cancer Institute congratulated Dr. Choueiri while tweeting “#ASCO21 @ASCO Plenary #LBA5: Keynote-564 trial results just out, in patients with high risk resected #kidneycancer: Pembrolizumab significantly improves disease free survival. Practice changing data”.


Reference: Choueiri, T. K., Tomczak, P., Park, S. H., Venugopal, B., Ferguson, T., Chang, Y. H., … & Powles, T. (2021). Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma. New England Journal of Medicine, 385(8), 683-694.


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