At 3 years of follow-up, nivolumab continued to show a benefit in disease-free survival (DFS), non-urothelial tract recurrence-free survival (RFS), and distant metastasis-free survival for patients with high-risk muscle-invasive urothelial carcinoma following radical resection.

Matt Galsky, MD, Icahn School of Medicine at Mount Sinai, New York, NY, presented the extended follow-up data from the CheckMate 274 trial on Friday, February 17, 2023, at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, CA.

The double-blind, phase 3, CheckMate 274 trial enrolled 699 patients with high-risk muscle-invasive urothelial carcinoma after radical resection. Patients were randomized on a 1-to-1 basis to receive 240 mg nivolumab every 2 weeks (n = 353) or placebo (n = 346) for up to 1 year of treatment. As previously reported, CheckMate 274 met its co-primary of end points of improved disease-free survival compared with placebo in the intent-to-treat population, and among patients with tumor PD-L1 expression ≥1%. Secondary end points included overall survival, non-urothelial tract RFS in both the intent-to-treat population and the PD-L1≥1% subgroup, while distant metastasis-free survival and safety were exploratory end points.

With a median follow-up of 36.1 months, the median DFS of the intent-to-treat population in the nivolumab arm was 22.0 months vs 10.9 months in the placebo arm. Among patients with PD-L1≥1%, the median DFS was 52.6 months in the nivolumab arm vs 8.4 months in the placebo arm. This benefit was seen across most prespecified subgroups (age, sex, ECOG performance status, etc). For non-urothelial tract RFS and distant metastasis-free survival, there was also a benefit in both populations with nivolumab vs placebo.

The incidence of grade 3/4 treatment-related adverse events was 18.2% in the nivolumab arm and 7.2% in the placebo arms. This safety profile was consistent with the primary analysis.

Dr Galsky and coauthors concluded, “These results further support adjuvant nivo[lumab] as a standard of care for high-risk [muscle-invasive urothelial cancer] after radical resection.”

Source:

Galsky M, Witjes AA, Gschwend JE, et al. Extended follow-up results from the CheckMate 274 trial. Presented at 2023 ASCO Genitourinary Cancers Symposium; February 17-19; San Francisco, CA. Abstract LBA443