FDA Nod for Adjuvant Pembrolizumab in Kidney Cancer 

Sharon Worcester

November 18, 2021

Pembrolizumab (Keytruda) has been granted approval from the US Food and Drug Administration for use as an adjuvant treatment following surgery in certain patients with renal cell carcinoma (RCC), making it the first immunotherapy to have this indication.  

Specifically, the approval is for the adjuvant treatment of patients with RCC who are at intermediate or high risk for recurrence after nephrectomy or after nephrectomy and resection of metastatic lesions.

The approval is based on findings from the pivotal phase 3 KEYNOTE-564 trial, which  showed a 32% reduction in the risk for disease recurrence or death with pembrolizumab vs placebo in this patient population (hazard ratio, 0.68).

There have previously been "no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence," the authors noted when this trial published in August in the New England Journal of Medicine. These trial results "herald the dawn of a new era in the treatment of renal cell carcinoma," commented Rana McKay, MD, a medical oncologist at the University of California San Diego Health, writing in an accompanying editorial.

This new option "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," commented study author Toni K. Choueiri, MD, in a press release about the approval. Choueiri is director the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts and a professor of medicine at Harvard Medical School.

The median duration of exposure to Keytruda in the KEYNOTE-564 trial was 11.2 months. Serious adverse reactions occurred in 20% of patients, and included acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (each occurring in 1% of patients). Fatal adverse reactions occurred in 0.2% of, including one case of pneumonia.

The trial will continue to assess overall survival (OS) as a secondary outcome measure.

During a discussion of the trial results at the American Society of Clinical Oncology meeting this past June, McKay noted the importance of the disease-free survival clinical benefit, but she also stressed the importance of longer follow-up for OS data.

Any decision to administer adjuvant therapy "needs to take into account the potential benefits of therapy with regards to curability and survival, balanced with the risks of treatment, including toxicities, impact on quality of life, and also financial cost," she said at the time.

Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network.

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