For patients with clear-cell renal cell carcinoma at high risk for recurrence after nephrectomy, adjuvant therapy with pembrolizumab improves disease-free survival, according to a study published in the Aug. 19 issue of the New England Journal of Medicine.
Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues randomly assigned patients with clear-cell renal cell carcinoma who were at high risk for recurrence after nephrectomy to receive either adjuvant pembrolizumab (496 patients) or placebo (498 patients) every three weeks for up to 17 cycles.
The median time from randomization to the data cutoff date was 24.1 months at the prespecified interim analysis. The researchers found that disease-free survival was significantly longer in association with pembrolizumab therapy versus placebo (disease-free survival at 24 months, 77.3 versus 68.1 percent; hazard ratio for recurrence, 0.68). The estimated proportion of patients who remained alive at 24 months was 96.6 and 93.5 percent in the pembrolizumab and placebo groups, respectively (hazard ratio for death, 0.54). Overall, 32.4 percent of those receiving pembrolizumab and 17.7 percent of those receiving placebo had grade 3 or higher adverse events of any cause; there were no deaths associated with pembrolizumab therapy.
“The growing global incidence of localized renal-cell carcinoma, paired with the persistent probability of disease recurrence after surgery, places emphasis on the usefulness of an effective adjuvant treatment strategy for patients with this tumor type,” the authors write.
The study was funded by Merck Sharp and Dohme, the manufacturer of pembrolizumab.