John Burke, MD, Discuses the Key Findings of the KEYNOTE-564 Trial With Pembrolizumab in High-Risk RCC

CancerNetwork®sat down with John Burke, MD, to talk about the topline results in the KEYNOTE-564 trial, which examined the use of pembrolizumab in a population of patients with high-risk renal cell carcinoma.

John Burke, MD, a heamtologist and medical oncologist from Rocky Mountain Cancer Centers, spoke to CancerNetwork® about the results of the phase 3 KEYNOTE-564 study (NCT03142334), which assessed the use of pembrolizumab (Keytruda) in patients with renal cell carcinoma who have a high risk of relapse following surgery. In addition to discussing eligibility criteria, Bruke highlighted the overall survival (OS) and disease-free survival (DFS) benefit with pembrolizumab compared with placebo.


In this trial, it was tested whether adding pembrolizumab after a surgical removal of kidney cancer reduced the risk of the cancer coming back. Most of the patients had cancer that was limited to the kidney, but there were a few patients whose cancers had spread to other parts of the body. They had all of their cancer removed surgically and then were eligible for this trial. In order to be eligible, patients had to have pretty sizable tumors or had to be at high risk of recurrence. [It could] not be a real small tumor that was removed; they had to have a high risk of recurrence [such as] either positive lymph nodes or other features of high-risk disease. They had to have completely removed tumors [with] no residual cancer left behind. They were then randomly assigned to receive either pembrolizumab or placebo.

Both treatments were administered intravenously once every 3 weeks for about 1 year. The median follow-up of the patients was [24.1 months] at the time of the reporting year. About [some] of the patients had metastases that had been removed, [and] the remainder just had kidney disease localized to the kidneys that was removed.

The primary endpoint of the study was to measure the DFS. What we found was that the DFS was [approximately] 32% better in patients treated with pembrolizumab compared with the placebo. If you look at the 2-year rates of DFS, it was 77.3% with pembrolizumab and 68.1% with the placebo. If you look at OS, it was 96.6% with pembrolizumab and 93.5% with the placebo at 2 years, appearing to favor the pembrolizumab arm, although longer follow-up is going to be needed to determine whether use of this drug truly impacts OS.


Choueiri TK, Tomczak P, Park SH, et al. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: Randomized, double-blind, phase III KEYNOTE-564 study. J Clin Oncol. 2021; 39(suppl 18).doi: 10.1200/JCO.2021.39.15_suppl.LBA5