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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 coi.asco.org.



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