John Burke, MD, Discuses the Rationale for Examining Pembrolizumab in High-Risk RCC After Surgery

CancerNetwork®sat down with John Burke, MD, to discuss why treatment with pembrolizumab post-surgery may be a promising option for patients with high-risk renal cell carcinoma.

John Burke, MD, a heamtologist and medical oncologist from Rocky Mountain Cancer Centers, spoke with CancerNetwork® about the reasoning behind the phase 3 KEYNOTE-564 study (NCT03142334), assessing pembrolizumab (Keytruda) in a population of patients with high-risk renal cell carcinoma (RCC) following surgery. Notably, several different drugs have already been examined in this patient population, which have yielded poor results. However, treatment with pembrolizumab appeared promising, due to its ability to aid patients’ immune ability in fighting off cancer.


After surgical removal of the kidney, there's a possibility that the cancer will still relapse and that risk is higher for patients with larger tumors, or whose tumors are invading into the vein or who have lymph node involvement around the kidney; the risk is higher of having a recurrence.

Historically, a number of drugs have been tried to reduce the risk of kidney cancer recurrence after surgery, like we do with many other cancers like breast and colon cancer. None of them have really worked with 1 exception, which is sunitinib [Sutent], which a few years ago was shown to be able to reduce the risk of recurrence but the benefit was pretty small, and the toxicities of sunitinib are quite significant. It took a long time for those [who] benefited to be evident. This was considered an area of need, where it was a goal to try to find a treatment that would be able to reduce the risk of relapse of kidney cancer after surgery.

That brings us to the drug that we studied in this trial, pembrolizumab, [which] is a monoclonal antibody that targets PD-1. Using pembrolizumab basically is improving the patient’s immune system's ability to attack the cancer cells. It's really a way of driving the patient's own immune system to attack cancer cells. We know that pembrolizumab is an effective treatment for patients with kidney cancer that has spread to other parts of the body, as well as many other cancers that have spread to other parts of the body.


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