Super-resolution image of a group of killer T cells (green and red) surrounding a cancer cell (blue, center). Credit: NIH

Pembrolizumab is the first drug approved as adjuvant therapy for patients with kidney cancer considered at high risk of relapse.

An immunotherapy drug given as a treatment following kidney cancer surgery, whose clinical testing was led by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, becomes a standard of care in kidney cancer.

The U.S. Food and Drug Administration (FDA) approved pembrolizumab, an anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-risk or high-risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. RCC is the most common form of kidney cancer.

The benefits of pembrolizumab in the adjuvant setting were borne out in the pivotal Phase 3 KEYNOTE-564 clinical trial. Choueiri is the lead author of the report which was published in The New England Journal of Medicine. Patients in the study demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo. Median DFS has not been reached for either group.

“Recurrence following surgery is common in renal cell carcinoma and despite decades of research, limited treatment options existed for patients whose cancer returned,” said Choueiri, who is the director of the Lank Center for Genitourinary Care at Dana-Farber and a professor of medicine at Harvard Medical School. “In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32% providing a promising new treatment option and potentially fundamental change in how we treat patients with kidney cancer considered at high risk of relapse.”

Read more on the KEYNOTE-564 trial here: Immunotherapy drug delays recurrence in kidney cancer patients.

Watch video: Dana-Farber's Toni K. Choueiri, MD details the impact of the study.