The initial results of the phase 3 CheckMate 274 trial were reported during the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium. Adjuvant nivolumab improved disease-free survival (DFS), non-urothelial tract recurrence-free survival (NUTRFS), and metastasis-free survival (MFS) compared to placebo for patients with muscle-invasive urothelial carcinoma.
Dr. Dean F. Bajorin 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 prior to surgery, (2) be ineligible for cisplatin-based chemotherapy, or (3) have declined cisplatin-based chemotherapy. The primary endpoint of 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 (P=0.0006). Among patients with PD-L1 ≥1%, DFS was 10.8 months for placebo and not reached yet for nivolumab (P=0.0004). Outcomes of NUTRFS and MFS were also improved, while disease-free and overall survival were not yet mature to report. Treatment-related grade 3-4 adverse events occurred for 17.9% of patients receiving nivolumab compared to 7.2% receiving placebo. The authors conclude the results “support adjuvant nivolumab as a new standard of care for patients with muscle-invasive urothelial carcinoma with high risk for recurrence despite neoadjuvant chemotherapy or those ineligible for and/or declining cisplatin-based chemotherapy.”
J Clin Oncol 39, 2021 (suppl 6; abstr 391)