CheckMate 274: Long-term Survival With Adjuvant Nivolumab for Patients With MIUC

For patients with muscle invasive urothelial carcinoma (MIUC) and radical cystectomy, the primary objectives of treatment are disease-free survival (DFS) and cure.

The phase 3 Checkmate 274 study, led by Daniel M. Geynisman, MD, and presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium, utilized mixture cure models to estimate the underlying cure fraction after radical resection for patients with high-risk MIUC.

Researchers prescribed patients to receive either nivolumab (n=353) or placebo (n=356). The majority of uncured patients were estimated to undergo recurrence within 5 years, according to selected models.

In the intention-to-treat population, for clinically plausible models, the estimated cure fraction fluctuated from 43.1% to 45.1% in the nivolumab group (95% CI, 36.7-51.6) and 36.4% to 37.0% in the placebo group (95% CI, 30.9-43.0). For the same patient population, the estimated range of 10-year mean DFS was 4.38 to 4.47 years in the nivolumab group and 3.61 to 3.64 years in the placebo group.

For patients diagnosed with tumor PD-L1 expression equal to or higher than 1% (PD-L1≥1%), the estimated cure fraction varied from 59.1% to 61.0% in the nivolumab cohort (95% CI, 48.9-72.0) and 35.9% to 36.9% in the placebo cohort (95% CI, 27.5-45.9). In the same patient population, the forecasted range of 10-year mean DFS was 5.54 to 5.65 years in the nivolumab cohort and 3.54 to 3.57 years in the placebo cohort.

Researchers concluded that for the adjuvant treatment of MIUC, in association with radical resection only, systemic therapy with nivolumab is connected to a cure fraction that is 6% to 9% higher in the intention-to-treat population.

They also noted that higher cure fractions in the nivolumab group were related to tumor PD-L1≥1% expression in patients. However, tumor PD-L1≥1% expression did not demonstrate significant alterations to the underlying cure fraction in the placebo group.