The 5-year results of the CheckMate 274 trial show that adjuvant nivolumab (Opdivo) provides lasting benefits for patients with high-risk muscle-invasive urothelial carcinoma (MIUC) after radical surgery.
With nearly five years of follow-up, nivolumab significantly improved outcomes compared with placebo. The median disease-free survival was 21.9 months with nivolumab, compared with 11.0 months with placebo—almost double. The treatment also improved disease-specific survival and reduced the risk of distant metastases. Overall survival was longer with nivolumab (75.0 months vs. 50.1 months), although this difference has not yet reached statistical significance, and follow-up continues. No new safety concerns were seen. The most common side effects remain itching, fatigue, and diarrhea.
The study also showed that circulating tumor DNA (ctDNA) can help predict who benefits most from treatment. Patients with detectable ctDNA after surgery—who are at higher risk of recurrence—had the greatest benefit from nivolumab. Those without detectable ctDNA had little additional benefit, suggesting some may already be cured by surgery alone. This means ctDNA testing may help doctors decide which patients truly need immunotherapy.