Merck & Co – known as MSD outside the US and Canada – has announced that Keytruda (pembrolizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) as an option for the adjuvant treatment of renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults....NICE’s decision is based on positive results from KEYNOTE-564, a multicentre, randomised, double-blind, placebo-controlled trial that enrolled 994 patients with clear cell RCC at increased risk of recurrence after nephrectomy who had not previously received systemic therapy.

Adjuvant pembrolizumab should be considered optional for patients with intermediate- or high-risk operable ccRCC (as defined by the study) after careful patient counselling regarding immature OS and potential long-term adverse events [I, C]....Adjuvant pembrolizumab can be offered to these patients after complete resection of their oligometastatic disease [II, B].

In a double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with clear-cell renal-cell carcinoma...Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P=0.002 [two-sided]).

In the multicentre, randomised, double-blind, placebo-controlled, phase 3 KEYNOTE-564 trial, adults aged 18 years or older with clear cell renal cell carcinoma...Participants were randomly assigned (1:1) via central permuted block randomisation (block size of four) to receive pembrolizumab...Disease-free survival was better with pembrolizumab compared with placebo (HR 0·63 [95% CI 0·50−0·80]).