As reported in the Journal of Clinical Oncology by Galsky et al, extended follow-up of the phase III CheckMate 274 trial supported the efficacy of adjuvant nivolumab in patients with muscle-invasive urothelial carcinoma at high risk of recurrence after radical resection.
Study Details
In the double-blind trial, 709 patients were randomly assigned to adjuvant nivolumab at 240 mg (n = 353) or placebo (n = 356) once every 2 weeks for ≤ 1 year. The primary analysis of the trial showed significant benefit of nivolumab in disease-free survival in the intent-to-treat (ITT) population and the population with tumor PD-L1 expression ≥ 1%. The current analysis shows disease-free survival outcomes after a median follow-up of 36.1 months.
Key Findings
Continued disease-free survival benefit was observed for nivolumab vs placebo. Median disease-free survival was 22.0 months vs 10.9 months (hazard ratio [HR] = 0.71, 95% confidence interval [CI] = 0.58–0.86; 3-year rates of 45.0% vs 34.9%) in the ITT population and 52.6 months vs 8.4 months (HR = 0.52, 95% CI = 0.37–0.72; 3-year rates of 56.9% vs 33.3%) in the PD-L1 ≥ 1% population.
A total of 279 patients in the nivolumab group and 281 in the placebo group had muscle-invasive bladder cancer. Significant benefits of nivolumab in disease-free survival in the muscle-invasive bladder cancer population were observed in both the ITT population and the PD-L1 ≥ 1% population.
On interim analysis, median overall survival was 69.5 months in the nivolumab group vs 50.1 months in the placebo group (HR = 0.76, 95% CI = 0.61–96; 3-year rates of 65.6% vs 58.1%) in the ITT population and not reached in either group (HR = 0.56, 95% CI = 0.36–0.86; 3-year rates of 71.3% vs 56.6%) in the PD-L1 ≥ 1% population.
No new safety signals were reported.
The investigators concluded: “Overall, these results further support adjuvant nivolumab as a standard of care for high-risk [muscle-invasive urothelial carcinoma] after radical resection.”
Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, New York, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Bristol Myers Squibb. For full disclosures of the study authors, visit ascopubs.org
