Kidney Cancer Coverage from Every Angle

ASCO 2021: KEYNOTE-564 Evaluates Pembrolizumab as Adjuvant Therapy After Nephrectomy

By: Julia Fiederlein
Posted: Friday, June 4, 2021

Patients with renal cell carcinoma derived a significant disease-free survival benefit from treatment with the PD-1 inhibitor pembrolizumab after nephrectomy, according to Toni K. Choueiri, MD, of the Dana‐Farber Cancer Institute, Boston, and colleagues. The results of the multicenter phase III KEYNOTE-564 trial, which were presented in a presscast in advance of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA5, Plenary).

“Given the success of pembrolizumab in the KEYNOTE-564 trial, this population may soon have a new standard of care,” said ASCO Chief Medical Officer and Executive Vice President Julie R. Gralow, MD, FACP, FASCO, in an ASCO press release.

A total of 994 patients with histologically confirmed clear cell renal cell carcinoma who underwent nephrectomy were randomly assigned in a 1:1 ratio to receive pembrolizumab or a placebo. Patients with intermediate-high–risk or high-risk disease were eligible; those with M1 tumors who had no evidence of disease after surgical resection were also enrolled. Follow-up data will be provided for a median of 24.1 months.

At the first prespecified interim analysis, the median duration of disease-free survival was not reached in both arms (hazard ratio = 0.68; P = .0010). The estimated disease-free survival rate at 24 months was 77.3% with pembrolizumab and 68.1% with the placebo. Overall, the disease-free survival benefit seemed to be consistent across subgroups. A total of 18 and 33 overall survival events were reported with pembrolizumab and the placebo, respectively. In both arms, the median duration of overall survival was not reached (hazard ratio = 0.54; P = .0164). The estimated overall survival rate at 24 months was higher with pembrolizumab than with the placebo (96.6% vs. 93.5%).

A total of 96.3% and 91.1% of patients experienced at least one all-cause adverse event with pembrolizumab and the placebo, respectively. Grade 3 to 5 all-cause adverse events were reported in 32.4% of patients treated with pembrolizumab and in 17.7% of those treated with the placebo. No pembrolizumab-related deaths were reported.

Disclosure: For full disclosures of the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.