On November 17, 2021, the FDA approved a new indication for Keytruda (pembrolizumab; from Merck), an immunotherapy, for the adjuvant (additional) treatment of patients with renal-cell carcinoma, or kidney cancer, that is at intermediate-high or high risk for recurrence (coming back) after nephrectomy (surgical removal of a kidney) or after nephrectomy and surgical removal of metastatic lesions.
This approval was evaluated in the KEYNOTE-564 study, a multicenter, randomized, double-blind, placebo-controlled clinical trial of 994 patients with kidney cancer. The patients received adjuvant therapy with Keytruda every 3 weeks or with placebo for up to 1 year, until their disease returned or until unacceptable side effects.
At an interim analysis, significant improvements were demonstrated in the number of patients who had disease-free survival with Keytruda compared with placebo.
The most common side effects with Keytruda in this study were musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism.
