Pembrolizumab Monotherapy Improves DFS in Patients With Renal Cell Carcinoma

Merck announced an interim analysis of pembrolizumab to treat RCC, finding a clinically significant improvement in disease-free survival when compared with placebo.

A phase 3 trial evaluating pembrolizumab (Keytruda) monotherapy as an adjuvant treatment for patients with renal cell carcinoma (RCC) following nephrectomy reported a clinical and significant improvement in disease-free survival (DFS) compared with placebo, according to an interim analysis announced in a press release by Merck.

The randomized, double-blind, phase 3 KEYNOTE-564 trial (NCT03142334) also reported a safety profile consistent with previous research at the interim analysis conducted by an independent Data Monitoring Committee.

“Since its first approval in renal cell carcinoma nearly two years ago, Keytruda has become an important first-line treatment option in combination with axitinib [Inlyta] for patients with advanced renal cell carcinoma,” Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, said in a press release.

The KEYNOTE-564 trial enrolled 950 patients with RCC who underwent nephrectomy and also have intermediate-high risk, high risk, or M1 no evidence of disease. The patient population was randomized to either pembrolizumab or placebo at 200 mg intravenously on day 1 of a 3-week cycle for up to 17 cycles.

While the interim data reported here focuses on the primary end point of DFS, the KEYTRUDA-564 trial will continue to evaluate a key secondary end points of overall survival and safety.

“These new data are the result of our research to evaluate the role of Keytruda in helping patients with earlier stages of disease and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma,” said Baynes. “We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”

Currently, pembrolizumab plus axitinib is approved in the United States, Europe, and Japan as a first-line treatment option for patients with advanced RCC. Regardless, Merck explains that pembrolizumab continues to be studied as both a monotherapy and in combination with other drugs to treat patients across multiple stages and settings of RCC.

RCC is the most common type of kidney cancer, accounting for 9 of every 10 cases. Globally in 2020, an estimated 431,300 new cases of kidney cancer were diagnosed, with an estimated 179,400 deaths. In the United States, an estimated 76,100 new cases will be diagnosed and approximately 13,800 death in 2021.


Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery. News release. Merck. Published April 8, 2021. Accessed April 8, 2021.