Efficacy of adjuvant pembrolizumab in renal-cell carcinoma

New data recently published on The New England Journal of Medicine show a significant and clinically meaningful improvement in overall survival in patients with renal-cell carcinoma treated with adjuvant pembrolizumab, previously shown to improve disease-free survival in these patients.

Pembrolizumab was approved in 2021 as adjuvant treatment for patients with renal-cell carcinoma who were at an intermediate-to-high or high risk for recurrence after nephrectomy, with or without the resection of metastatic lesions. The approval was based on the significant and clinically meaningful improvement in disease-free survival that was observed with pembrolizumab in the phase 3, double-blind, randomized, placebo-controlled KEYNOTE-564 trial, where the estimated disease-free survival at 24 months with pembrolizumab was 77.3% vs. 68.1% with placebo. This paper presents new data for the secondary endpoint of overall survival; a total of 496 patients with renal-cell carcinoma who had an increased risk of recurrence after surgery were assigned to receive pembrolizumab and 498 to receive placebo. At a median follow-up of 57.2 months, the disease-free survival benefit was consistent with that in previous analyses; the estimated overall survival at 48 months was 91.2% in the pembrolizumab group, as compared with 86% in the placebo group; the benefit was consistent across key subgroups. Pembrolizumab was associated with a higher incidence of serious adverse events of any cause (20.7%, vs. 11.5% with placebo). «This phase 3 trial showed improved overall survival with an adjuvant therapy among patients with renal-cell carcinoma who were at increased risk for disease recurrence after nephrectomy with or without metastasectomy. These results further support the use of adjuvant pembrolizumab as a standard intervention after surgery in this disease context», authors conclude.