HealthDay News — For patients with high-risk muscle-invasive urothelial carcinoma who have had radical surgery, disease-free survival is significantly longer with nivolumab than placebo, according to a study published in the June 3 issue of the New England Journal of Medicine.

Dean F. Bajorin, MD, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues conducted a phase 3 double-blind trial involving patients with muscle-invasive urothelial carcinoma who had undergone radical surgery. Participants were randomly assigned to receive nivolumab or placebo (353 and 356, respectively) every 2 weeks for up to 1 year.

The researchers found that in the intention-to-treat population, median disease-free survival was 20.8 months with with nivolumab and 10.8 months with placebo. The percentage of patients who were alive and disease-free at 6 months was 74.9 and 60.3%, respectively (hazard ratio for disease recurrence or death, 0.70). Among those with a programmed death ligand 1 (PD-L1) expression level of 1 percent or more, the corresponding percentage of patients was 74.5 and 55.7% (hazard ratio, 0.55). At 6 months, the percentage of patients who were alive and free from recurrence outside the urothelial tract was 77.0% with nivolumab and 62.7% with placebo (hazard ratio for recurrence outside the urothelial tract or death, 0.72). Among those with PD-L1 expression of 1% or more, the percentages were 75.3 and 56.7%, respectively (hazard ratio, 0.55).

“The CheckMate 274 trial showed a significant and clinically meaningful benefit of adjuvant systemic immunotherapy as compared with placebo,” the authors write.

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Several authors disclosed financial ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures nivolumab and funded the study.

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