Adjuvant Pembrolizumab Approved by FDA for Treatment of Renal Cell Carcinoma in Certain Cases

Patients with intermediate-risk and high-risk renal cell carcinoma had a statistically significant improvement in disease-free survival after being treated with pembrolizumab, which was approved by the FDA.

The FDA has approved pembrolizumab (Keytruda) as an adjuvant treatment for renal cell carcinoma (RCC) in patients who have a high or intermediate risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.

The drug was evaluated as part of the phase 3 KEYNOTE-564 trial (NCT03142334) in 994 patients with intermediate- or high-risk RCC. Findings from the prespecified analysis indicated that a statistically significant improvement in disease-free survival (DFS) was observed, with 22% of patients experiencing an event in the pembrolizumab vs 30% in the placebo arm (HR, 0.68; 95% CI, 0.53-0.87; P = .001). Notably, the median DFS was not reached in either arm. The OS data were not mature at the time of DFS analysis, as only 5% of deaths had occurred within the total patient population.

The most common adverse effects included musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism.


FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma. News release. FDA. November 17, 2021. Accessed November 17, 2021.