FDA approves Keytruda for adjuvant treatment of renal cell carcinoma
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The FDA expanded the approval of pembrolizumab to include adjuvant treatment of certain patients with renal cell carcinoma.
The indication applies to use of the agent by patients at intermediate-high or high risk for recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is approved in the United States for several oncology indications, including in combination with axitinib (Inlyta, Pfizer) for first-line treatment of adults with advanced renal cell carcinoma.
The FDA based the new indication on results of the randomized phase 3 KEYNOTE-564 trial, which included 994 patients with renal cell carcinoma at intermediate-high or high risk for recurrence. All patients underwent nephrectomy.
Researchers assigned patients to 200 mg pembrolizumab via IV or placebo on day 1 of each 3-week cycle. Treatment continued for up to 1 year, or until disease recurrence or unacceptable toxicity.
DFS served as the primary endpoint. Secondary endpoints included OS and safety.
As Healio previously reported, results showed a statistically significant improvement in DFS among patients assigned pembrolizumab (HR = 0.68; 95% CI, 0.53-0.87). Median DFS had not been reached in 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,” Toni K. Choueiri, MD, director of Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, said in a Merck-issued press release. “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.”
The most common adverse events reported among pembrolizumab-treated patients included musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%) and hypothyroidism (21%).
Twenty percent of patients assigned pembrolizumab experienced serious adverse events. These included acute kidney injury, adrenal insufficiency, pneumonia, colitis and diabetic ketoacidosis (1% each). Researchers reported one fatal case of pneumonia.
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