Highlights in Renal Cell Carcinoma from ASCO GU 2022

KEYNOTE-564 30 months follow-up update: adjuvant pembrolizumab continued to improve DFS in patients with ccRCCBased on positive results from the ongoing phase III KEYNOTE-564 trial, pembrolizumab was approved as adjuvant treatment in clear-cell renal cell carcinoma (ccRCC) by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), but not yet by Swissmedic. 1,2his trial enrolled 994 patients with ccRCC, who met the protocol-defined criteria for intermediate-high risk, high risk or M1 no evidence of disease (NED), defined as resection of primary tumor and metastases. 3,4Patients received either pembrolizumab (200 mg intravenously every three weeks) (n=496) or placebo (n=498) for up to one year.The primary endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS) and safety.Compared with data from the 24.1-month analysis presented at the 2021 ASCO Annual Meeting, 3 the updated analysis at a median follow-up of 30.1 months, which was requested by the regulatory authorities, showed a further DFS improvement with pembrolizumab versus placebo in the intention-to-treat population (HR: 0.63 [95% CI: 0.50-0.80];p<0.0001). 4This DFS benefit was preserved across all key subgroups, including patients with M0 disease with intermediate-high risk of recurrence (HR 0.68 [95% CI: 0.52-0.89]),M0 with a high risk of recurrence (HR: 0.60 [95% CI: 0.33-1.10])and M1 NED (HR: 0.28 [95% CI: 0.12-0.66]).When stratified by sarcomatoid status, pembrolizumab versus placebo improved DFS in both patients with tumors without