Balar AV et al. -Greater than one-half of patients with advanced urothelial cancer are not candidates for standard, first-line cisplatin-based chemotherapy. In the current study, pembrolizumab was shown to have good efficacy and was well-tolerated in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer.

Methods

• Cisplatin-ineligible patients with advanced urothelial cancer who had not been previously treated with systemic chemotherapy were recruited from 91 academic medical centres in 20 countries.
• Patients received intravenous pembrolizumab 200 mg every 3 weeks.

Results

• 370 patients received at least 1 dose of pembrolizumab.
• 89 of 370 patients had an objective response.
• The median follow-up was 5 months.
• A PD-L1-expression cut-off of 10% was associated with a higher frequency of response to pembrolizumab. 42 of 110 patients with a combined positive score of 10% or more had an objective response.
• The most common grade 3 or 4 treatment-related adverse events were fatigue, alkaline phosphatase increase, colitis, and muscle weakness.