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ASCO GU 2023: Extended Follow-up From CheckMate 274 With Nivolumab for High-Risk Urothelial Carcinoma

By: Sarah Lynch
Posted: Thursday, March 9, 2023

Researchers evaluated the efficacy of the PD-1 inhibitor nivolumab in improving disease-free survival versus placebo for high-risk muscle-invasive urothelial carcinoma (bladder, ureter, or renal pelvis) after radical resection, in the CheckMate 274 trial. Extended follow-up from this study, which was presented during the 2023 American Society for Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract LBA443), focused on the intent-to-treat population of patients with PD-L1 expression of at least 1%.

“These results further support adjuvant nivolumab as a standard of care for high-risk muscle-invasive urothelial carcinoma after radical resection,” according to Matt D. Galsky, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues.

A total of 353 patients were randomly assigned to receive nivolumab and 356, placebo. After a median follow-up of 36.1 months, the median disease-free survival was 22.0 months with nivolumab and 10.9 months with placebo for the intent-to-treat patients and 52.6 months with nivolumab and 8.4 months with placebo for patients with PD-L1 expression of at least 1%. Nivolumab was seen to improve disease-free survival in subgroups analyzed by age, sex, Eastern Cooperative Oncology Group performance status, nodal status, prior cisplatin-based chemotherapy, and PD-L1 status. Benefits with nivolumab were also reported in terms of non–urothelial tract recurrence-free survival and distant metastasis–free survival.

In terms of toxicity, grade 3 or 4 treatment-related adverse events occurred in 18.2% and 7.2% of patients in the nivolumab and placebo arms; these findings were consistent with those in the primary analysis. The investigators noted that overall survival will be assessed at a future database lock.

Disclosure: For full disclosures of the study authors, visit

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