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Pembrolizumab Yields Significantly Longer DFS Than Placebo in Renal Cell Carcinoma
Currently, there are no available options in adjuvant therapy to reduce the high risk of recurrence in patients with renal cell carcinoma after nephrectomy. A double-blind, phase 3 trial was developed to evaluate an optimal treatment regimen for this patient population.
“We randomly assigned (1:1) patients with clear-cell renal cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either adjuvant pembrolizumab 200 mg or placebo intravenously once every 3 weeks for up to 17 cycles,” explained Toni Choueiri, MD, Dana-Farber Cancer Institue, Boston, MA, and co-investigators.
The primary endpoint was disease-free survival (DFS) with secondary endpoints being overall survival (OS) and safety.
Out of 994 patients enrolled, 496 were randomly assigned to receive pembrolizumab and 498 to placebo. The median time from randomization to the data-cutoff date was 24.1 months.
Findings highlight that pembrolizumab was associated with significantly longer DFS than placebo (DFS at 24 months, 77.3% versus 68.1%; hazard ratio [HR] for recurrence or death, 0.68; 95% CI 0.53 to 0.87; p=0.002).
The percentage of patients who survived treatment and disease after 24 months was 96.6% in the pembrolizumab group and 93.5% in the placebo group (HR for death, 0.54; 95% CI 0.30-0.96).
Grade 3 or higher adverse events (AEs) occurred in 32.4% of patients inducted to pembrolizumab and in 17.7% of those who received placebo. There were no reports of death related to treatment.
“Pembrolizumab treatment led to a significant improvement in DFS as compared with placebo after surgery among patients with kidney cancer who were at high risk for recurrence,” concluded Dr Choueiri, et al. – Alexa Stoia
