Adjuvant Nivolumab Improves Disease-Free Survival for Patients with Muscle-invasive Urothelial Carcinoma in CheckMate 274

INITIAL RESULTS of the phase 3 CheckMate 274 trial were reported during the 2021 ASCO Genitourinary Cancers Symposium. Adjuvant nivolumab improved disease-free survival (DFS), non-urothelial tract recurrence-free survival (NUTRFS), and metastasis-free survival (MFS) compared with placebo for patients with high-risk muscle-invasive urothelial carcinoma (bladder, ureter, or renal pelvis) after radical surgery. Standard of care in these patients would usually be cisplatin-based neoadjuvant therapy followed by radical surgery.

Dr. Dean F. Bajorin (Memorial Sloan Kettering Cancer Center, New York) and colleagues reported that 709 patients were randomized to receive nivolumab or placebo for up to 1 year after radical surgery. Included patients were allowed to (1) have received cisplatin-based neoadjuvant chemotherapy, (2) be ineligible for cisplatin-based chemotherapy, or (3) have declined cisplatin-based chemotherapy. The primary endpoint, DFS, was assessed among the overall population and among those with ≥1% PD-L1 expression.

In the overall population, median DFS was increased from 10.9 months for placebo to 21.0 months for nivolumab (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.54-0.89; P=0.0006). A similar effect was seen among patients with PD-L1 ≥1%: DFS was 10.8 months for placebo and not yet reached for nivolumab (HR 0.53; 95% CI, 0.34–0.84; P=0.0004). Outcomes of NUTRFS and MFS were also improved. Treatment-related grade 3-4 adverse events occurred for 17.9% of patients receiving nivolumab compared with 7.2% receiving placebo. The study investigators concluded that their results support adjuvant nivolumab as a new standard of care for patients with muscle-invasive urothelial carcinoma at high risk for recurrence despite neoadjuvant chemotherapy or for patients who are ineligible for or decline cisplatin-based chemotherapy.

Hiten D. Patel, MD, MPH, completed residency training in urologic surgery at the James Buchanan Brady Urological Institute and is currently a Clinical Instructor and Fellow in Urologic Oncology at Loyola University Medical Center. He has published studies related to epidemiology, comparative effectiveness, evidence-based reviews, and clinical trials in urologic oncology and related fields.


First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab vs. placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma (MIUC). J Clin Oncol 39, 2021;39(6, suppl):99.{; Abstract 391. doi: 10.1200/JCO.2021.39.6_ suppl.391