On November 17, 2021, the Food and Drug Administration approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 

Efficacy was evaluated in KEYNOTE-564 (NCT03142334), a multicentre, randomized (1:1), double-blind, placebo-controlled trial in 994 patients with intermediate-high or high risk of recurrence of RCC, or M1 no evidence of disease.

Patients were randomised to pembrolizumab 200 mg intravenously every 3 weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity.

The major efficacy outcome measure was investigator-assessed disease-free survival (DFS), defined as time to recurrence, metastasis, or death.

An additional outcome measure was overall survival (OS). 

A statistically significant improvement in DFS was demonstrated at a prespecified interim analysis, with 109 (22%) events in the pembrolizumab arm and 151 (30%) events in those receiving placebo (HR 0.68; 95% CI: 0.53, 0.87; p=0.0010).

Median DFS was not reached in either arm.

At the time of the DFS analysis, OS data were not mature, with 5% deaths in the overall population.

The most common adverse reactions (≥20%) occurring in patients on this trial were musculoskeletal pain, fatigue, rash, diarrhoea, pruritus, and hypothyroidism.  

The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months. 

View full prescribing information for pembrolizumab here. 

Source: FDA