Pembrolizumab has potential as a first-line treatment option for patients with locally advanced, unresectable, or metastatic urothelial cancer who are ineligible for cisplatin, according to a study published in Lancet Oncology.1

Approximately 50% of patients with advanced urothelial carcinoma are unable to receive the standard first-line cisplatin-based chemotherapy because of various comorbidities, renal dysfunction, or poor performance status, indicating a need for additional treatment options.

For the single-arm, phase 2 KEYNOTE-052 study ( Identifier: NCT02335424), researchers treated 370 chemotherapy-naïve patients with at least 1 dose of intravenous pembrolizumab 200 mg every 3 weeks. Tumor samples were analyzed to determine PD-L1 expression.

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At a median follow-up of 5 months, 89 (24%; 95% CI, 20%-29%) patients achieved a centrally assessed objective response. Median time to response was 2 months.

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Patients with PD-L1-expression greater than 10% demonstrated a higher frequency of response to therapy. Forty-two (38%) patients with a combined positive score of 10% or greater had an objective response.

The most common grade 3 to 4 adverse events (AE) reported were fatigue, alkaline phosphatase increase, colitis, and muscle weakness. Ten percent of study patients experienced a serious treatment-related AE. One death was caused by a treatment-related AE, and 17 patients died from non-treatment related AEs.

The authors concluded that “in view of the antitumour activity and favourable safety profile, pembrolizumab has become a new treatment option for patients who are cisplatin-ineligible and for those who might not be suitable candidates for chemotherapy.”


  1. Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Sep 26. doi: 10.1016/S1470-2045(17)30616-2 [Epub ahead of print]