FDA Approves Pembrolizumab as Adjuvant Therapy for Renal Cell Carcinoma Following Surgery


Pembrolizumab demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% compared to placebo.

Officials with the FDA have approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

The approval is based on data from the pivotal phase 3 KEYNOTE-564 trial. Pembrolizumab demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% compared to placebo. Median disease-free survival has not been reached for either group.

“Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence,” said Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute, in a press release. “In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence.”

RCC is the most common form of kidney cancer , as approximately 9 out of 10 kidney cancer diagnoses are RCC. The disease is about twice as common in men than in women and most cases are discovered incidentally during imaging tests for other abdominal diseases. Pembrolizumab, an anti-programmed death receptor-1 (PD-1) therapy, works by increasing the ability of the immune system to detect and fight the tumor cells.

“Keytruda is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma,” said Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, in the press release.

The KEYNOTE-564 trial evaluated pembrolizumab as adjuvant therapy for RCC in 994 patients who have undergone a partial nephroprotective or radical complete nephrectomy with negative surgical margins for at least 4 weeks prior to the time of screening. Patients were excluded if they had received prior systemic therapy for advanced RCC.

In the trial, the median duration of exposure to pembrolizumab was 11.1 months and serious adverse reactions occurred in 20% of patients receiving pembrolizumab. Serious adverse reactions included acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis. Fatal adverse reactions occurred in 0.2% of patients treated with pembrolizumab, including 1 case of pneumonia.

Adverse reactions leading to discontinuation occurred in 21% of patients receiving pembrolizumab and the most common were increased alanine aminotransferase (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions in the pembrolizumab arm were musculoskeletal pain (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).

“With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients,” Choueiri said in the press release.


FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery. News release. Merck; November 18, 2021. Accessed November 18, 2021. https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-as-adjuvant-therapy-for-certain-patients-with-renal-cell-carcinoma-rcc-following-surgery/

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