Kidney Cancer Coverage from Every Angle

AUA 2021: KEYNOTE-564 Focuses on Adjuvant Immunotherapy for Renal Cell Carcinoma

By: Kayci Reyer
Posted: Tuesday, September 14, 2021

Research from the phase III KEYNOTE-564 trial, presented during the 2021 American Urological Association (AUA) Annual Meeting (Abstract PLLBA-01), suggested that patients with renal cell carcinoma who have a high post-surgical risk of recurrence may benefit significantly from receiving adjuvant pembrolizumab treatment. Toni Choueiri, MD, of Dana-Farber Cancer Institute in Boston, and colleagues evaluated disease-free survival of patients receiving adjuvant pembrolizumab versus patients receiving placebo.

“KEYNOTE-564 is the first positive phase III study with adjuvant immunotherapy in [renal cell carcinoma], and these results support pembrolizumb as a potential new standard of care for patients with [renal cell carcinoma] in the adjuvant setting,” concluded the authors.

The trial included 994 patients with clear cell renal cell carcinoma who had undergone surgery no more than 12 weeks prior to enrollment. Patients were randomly assigned to receive either pembrolizumab (n = 496) or placebo (n = 498). Disease-free survival was not reached for either arm, whereas estimated disease-free survival at 24 months was 77.3% with pembrolizumab and 68.1% with placebo. Disease-free survival did not appear to differ based on subgroup.

The median overall survival was not reached for either arm. Estimated overall survival at 24 months was 96.6% with pembrolizumab versus 93.5% with placebo. The majority of patients in both arms experienced adverse events of at least grade 1 (96.3% with pembrolizumab vs. 91.1% with placebo), but all-cause adverse events of grade 3 to 5 were almost twice as common among patients receiving pembrolizumab (32.4%) than among those receiving placebo (17.7%). No treatment-related deaths were reported within the pembrolizumab group.

Disclosure: For full disclosures of the study authors, visit

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