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GU Cancers Symposium: Pembrolizumab in Advanced Urothelial Cancer

By: PharmD
Posted: Saturday, February 10, 2018

Pembrolizumab continues to show an overall survival benefit versus chemotherapy in patients with advanced urothelial cancer, according to the 2-year update released from the KEYNOTE-045 trial by Joaquim Bellmunt, MD, PhD, Director of the Bladder Cancer Center at Dana-Farber Cancer Institute, Boston, and colleagues, which was presented at the 2018 Genitourinary Cancers Symposium in San Francisco (Abstract 410). The initial results and interim analyses from this phase III study led to the approval of pembrolizumab as a second-line agent for patients with locally advanced or metastatic urothelial cancer that progressed during or after platinum-based therapy.

The 542 patients with advanced urothelial cancer that progressed during or after platinum-based chemotherapy were randomized to receive pembrolizumab at 200 mg every 3 weeks or investigator’s choice of chemotherapy with paclitaxel, docetaxel, or vinflunine. At a median follow-up of 27.7 months, median overall survival was 10.3 months with pembrolizumab versus 7.3 months with chemotherapy (hazard ratio = 0.70; P < .0002). Overall survival benefit was seen in all PD-L1 expression subgroups. Pembrolizumab had a better safety profile than chemotherapy, with grade ≥ 3 treatment-related adverse events occurring more often in those who received chemotherapy (50.2% vs. 16.5%).