Adjuvant nivolumab following radical surgery for high-risk muscle-invasive urothelial carcinoma significantly improves disease-free survival compared with placebo, according to a recent study.

Nivolumab is a monoclonal antibody directed against programmed death 1 (PD-1).

For the CheckMate 274 trial (NCT02632409), investigators randomly assigned 353 patients to receive nivolumab 240 mg intravenously and 356 to receive placebo every 2 weeks for 1 year. All patients had undergone radical surgery within 120 days of randomization. The tumor origin at diagnosis was the urinary bladder in the majority of patients (79% of the nivolumab group and 78.9% of the placebo group). The median follow-up duration was 20.9 months for the nivolumab group and 19.5 months for placebo recipients.

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The median disease-free survival in the intention-to-treat population was 20.8 months with nivolumab and 10.8 months with placebo, Dean F. Bajorin, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and colleagues reported in The New England Journal of Medicine. The proportion of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo. Nivolumab was significantly associated with a 30% decreased risk for disease recurrence or death compared with placebo.

Among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or higher, the percentages were 74.5% and 55.7%, respectively, with nivolumab significantly associated with a 45% reduced risk for disease recurrence or death compared with placebo.

In both trial populations, nivolumab-treated patients had significantly longer survival times free from recurrence outside the urothelial tract and longer distant metastasis-free survival, according to the investigators.

Treatment-related adverse events of grade 3 or high occurred in 17.9% of the nivolumab group and 7.2% of placebo recipients.

Dr Bajorin’s team noted that their interim analysis is limited by the short duration of follow-up. At a median follow-up of approximately 20 months, however, 48.2% of the patients in the nivolumab group and 57.3% of those in the placebo arm already had experienced disease recurrence or had died, they pointed out.

Disclosure: This research was supported by Bristol Myers Squibb and Ono Pharmaceutical. Please see the original reference for a full list of disclosures.


Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384;2102-2114. doi:10.1056/NEJMoa20334442