LAUSR

A phase III randomized, controlled trial has investigated the role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery. Patients with muscleinvasive cancer who had undergone radical cystectomy received nivolumab (240 mg intravenously; n = 353) or placebo (n = 356) every 2 weeks for up to 1 year. Median diseasefree survival in the intentiontotreat population was 20.8 months (95% CI 16.5– 27.6) with nivolumab and 10.8 months (95% CI 8.3–13.9) with placebo; 74.9% of those who received nivolumab were alive and diseasefree at 6 months compared with 60.3% of the placebo group (hazard ratio for disease recurrence or death 0.70; 98.22% CI 0.55–0.90; P < 0.001), increasing to 74.5% and 55.7%, respectively (HR 0.55; 98.72% CI 0.35–0.85; P < 0.001), in patients who had a PDL1 expression level of >1%. Grade ≥3 adverse events were reported in 17.9% of the nivolumab group and 7.2% of the placebo group, with two treatmentrelated deaths due to pneumonitis in the nivolumab group.