Extended follow-up data from the phase III CheckMate 274 trial demonstrates the sustained efficacy of adjuvant nivolumab in patients with high-risk muscle-invasive urothelial carcinoma following radical resection. The study, led by Galsky et al. and published in the Journal of Clinical Oncology, reinforces nivolumab as a standard of care for this patient population.
CheckMate 274 Trial: Extended Follow-Up
The double-blind trial involved 709 patients randomized to receive either adjuvant nivolumab at 240 mg (n = 353) or placebo (n = 356) every 2 weeks for up to 1 year. The primary analysis had previously shown a significant disease-free survival benefit with nivolumab in both the intent-to-treat (ITT) population and in patients with tumor PD-L1 expression ≥ 1%. This analysis reports disease-free survival outcomes after a median follow-up of 36.1 months.
Sustained Disease-Free Survival Benefit
The extended follow-up confirmed a continued disease-free survival benefit with nivolumab compared to placebo. In the ITT population, the median disease-free survival was 22.0 months versus 10.9 months (HR = 0.71, 95% CI = 0.58–0.86), with 3-year rates of 45.0% versus 34.9%. Among patients with PD-L1 expression ≥ 1%, the median disease-free survival was 52.6 months versus 8.4 months (HR = 0.52, 95% CI = 0.37–0.72), with 3-year rates of 56.9% versus 33.3%.
Notably, 279 patients in the nivolumab group and 281 in the placebo group had muscle-invasive bladder cancer. Significant disease-free survival benefits with nivolumab were observed in this subgroup, in both the ITT and PD-L1 ≥ 1% populations.
Overall Survival Improvement
An interim analysis of overall survival showed a median overall survival of 69.5 months in the nivolumab group compared to 50.1 months in the placebo group (HR = 0.76, 95% CI = 0.61–0.96), with 3-year rates of 65.6% versus 58.1% in the ITT population. In the PD-L1 ≥ 1% population, overall survival was not reached in either group (HR = 0.56, 95% CI = 0.36–0.86), with 3-year rates of 71.3% versus 56.6%.
Safety Profile
The study reported no new safety signals, further supporting the use of adjuvant nivolumab in this setting.
According to the investigators, “Overall, these results further support adjuvant nivolumab as a standard of care for high-risk [muscle-invasive urothelial carcinoma] after radical resection.”
