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CheckMate 274: Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinoma

By: Lauren Harrison, MS
Posted: Monday, September 27, 2021

Among patients with muscle-invasive urothelial carcinoma who undergo radical surgery and are treated with adjuvant nivolumab, disease-free survival was found to be longer when compared with those treated with placebo. Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, New York and colleagues published their findings from the phase III multicenter CheckMate 274 trial in The New England Journal of Medicine.

This double-blind, randomized, controlled trial enrolled 709 patients with muscle-invasive urothelial carcinoma. Patients underwent radical surgery and were randomly assigned 1:1 to receive 240 mg of intravenous nivolumab or placebo every 2 weeks for up to 1 year. Patients who had undergone neoadjuvant chemotherapy with cisplatin were allowed to enroll as well.

The median disease-free survival among the intention-to-treat population was 20.8 months in the nivolumab group, compared with 10.8 months in the placebo group. After 6 months of therapy, the percentage of patients who were both alive and free of disease was 74.9% in the group receiving nivolumab treatment and 60.3% in the group receiving the placebo (hazard ratio for disease recurrence of death = 0.70, P < .001). In addition, patients in the nivolumab group had a median survival free from recurrence outside of the urothelial tract of 22.9 months, compared with 13.7 months in the placebo group.

Patients were tested for PD-L1 expression. Among those with an expression of 1% of more, 74.5% of the nivolumab group was disease free and alive at 6 months, compared with 55.7% of the placebo group (hazard ratio = 0.55). In addition, 75.3% of patients treated with nivolumab did not have recurrence outside of the urothelial tract at 6 months, compared with 56.7% of those treated with the placebo (hazard ratio = 0.55).

Grade 3 or higher adverse events occurred in 17.9% of patients receiving nivolumab and 7.2% of patients receiving the placebo. There were two deaths due to pneumonitis and one death due to bowel perforation in the nivolumab group, and all three deaths were considered related to treatment.

Disclosure: For a full list of author disclosures, visit www.nejm.org.



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