MONDAY, June 14, 2021 (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, M.D., 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 two weeks for up to one 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 six months was 74.9 and 60.3 percent, 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 percent (hazard ratio, 0.55). At six months, the percentage of patients who were alive and free from recurrence outside the urothelial tract was 77.0 percent with nivolumab and 62.7 percent with placebo (hazard ratio for recurrence outside the urothelial tract or death, 0.72). Among those with PD-L1 expression of 1 percent or more, the percentages were 75.3 and 56.7 percent, 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.
Several authors disclosed financial ties to pharmaceutical companies, including Bristol Myers Squibb, which manufactures nivolumab and funded the study.
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