Writing History in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC): The Magic Goal of an Overall Survival Benefit Was Reached as Reported at ASCO GU 2024

Dear Colleagues,The road was rough for trials investigating adjuvant treatments in clear cell renal cell carcinoma (ccRCC).3][4][5][6] Only sunitinib in the phase III STRAC trial reached its primary endpoint of disease-free survival (DFS), but not OS and the rate of treatment discontinuation was excessively high, so sunitinib, although approved by the U.S. Food and Drug Administration (FDA), has never been nominated a standard of care. 7At the end of 2023 a press release has arrived that the phase III KEYNOTE-564 trial, randomizing patients to one year of adjuvant treatment with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab versus placebo, was positive for OS. 8 The primary endpoint of DFS was already reached in 2021.Since then, we have critically discussed with patients the possibility of receiving adjuvant treatment with pembrolizumab.][11] Contemporarily at ASCO GU 2024, also part A of the CheckMate 914 study with six months of Nivo versus placebo was reported to be negative. 12In summary, the KEYNOTE-564 trial is the only adjuvant trial in ccRCC that has proven DFS and recently an OS benefit. 1 The relative risk for death or progression was reduced by 38% by administering 1-year pembrolizumab compared to placebo.