Jan 2022: Pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy plus resection of metastatic lesions.
Efficacy was assessed in 994 patients with intermediate-high or high risk of recurrence of RCC, or M1 no evidence of illness, in KEYNOTE-564 (NCT03142334), a multicenter, randomised (1:1), double-blind, placebo-controlled trial. Patients were given either pembrolizumab 200 mg intravenously every 3 weeks or placebo for up to a year, or until illness recurrence or intolerable toxicity, whichever came first.
Disease-free survival (DFS), defined as the period between recurrence, metastasis, or death, was the primary effectiveness outcome measure. Overall survival was another outcome metric (OS). A prespecified interim analysis revealed a statistically significant improvement in DFS, with 109 (22%) occurrences in the pembrolizumab arm and 151 (30%) events in the placebo arm (HR 0.68; 95 percent CI: 0.53, 0.87; p=0.0010). In neither arm, the median DFS was reached. OS data were not complete at the time of the DFS analysis, with 5% of the population dying.
Musculoskeletal discomfort, weariness, rash, diarrhoea, pruritus, and hypothyroidism were the most common adverse effects in this experiment (20 percent).
Pembrolizumab is given in doses of 200 mg every three weeks or 400 mg every six weeks until illness recurrence, intolerable toxicity, or up to 12 months.
Click here for full prescribing information for Keytruda.