Single-agent treatment with nivolumab provided meaningful clinical benefit for previously treated patients with metastatic or unresectable urothelial carcinoma regardless of PD-L1 expression, according to a study published in The Lancet Oncology.1

Limited treatment options are available for patients with metastatic urothelial carcinoma who progress on or after first-line platinum-containing chemotherapy. Responses to second-line therapy are uncommon.

Nivolumab is a fully humanized IgG4 PD-1 immune checkpoint inhibitor antibody that has demonstrated substantial and durable clinical response with a manageable safety profile among previously treated patients with locally advanced or metastatic urothelial carcinoma who progressed after prior platinum-based chemotherapy.

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In this international, phase 2 study (CheckMate 275; Identifier: NCT02387996), researchers evaluated the activity and safety of nivolumab monotherapy among patients with metastatic or surgically unresectable urothelial carcinoma who experienced disease progression or recurrence despite previous therapy with at least 1 platinum-based chemotherapy regimen.

Investigators enrolled 270 patients with metastatic or surgically unresectable locally advanced transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis. All participants received intravenous nivolumab every 2 weeks until disease progression, unacceptable toxicity, or clinical deterioration.

Median follow-up was 7 months. Nearly 20% (95% CI, 15.0-24.9) of the 265 evaluable patients achieved a confirmed objective response.

Investigators found that 28.4% (95% CI, 18.9-39.5) of the 81 patients with PD-L1 expression of 5% or greater, 23.8% (95% CI, 16.5-32.3) of the 122 patients with PD-L1 expression of 1% or greater, and 16.1% (95% CI, 10.5-23.1) of the 143 patients with PD-L1 expression less than 1% achieved an objective response.

RELATED: Pembrolizumab Demonstrates Anti-tumor Activity, Acceptable Safety Profile in Urothelial Cancer

Eighteen percent of patients experienced grade 3 to 4 treatment-related adverse events, of which the most common were grade 3 fatigue and diarrhea. Three patients died from treatment-related adverse events, including pneumonitis, acute respiratory failure, and cardiovascular failure.


  1. Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Jan 25. doi: 10.1016/S1470-2045(17)30065-7 [Epub ahead of print]