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Pembrolizumab as Second-Line Treatment for Advanced Urothelial Carcinoma

By: Meg Barbor, MPH
Posted: Thursday, July 20, 2017

As second-line treatment in patients with advanced urothelial cancer whose disease progressed after platinum-based treatment, pembrolizumab improved overall survival by about 3 months compared with investigator’s choice of chemotherapy, according to data from the phase III international KEYNOTE-045 trial. These findings were published by Joaquim Bellmunt, MD, PhD, Director of the Bladder Cancer Center at Dana-Farber Cancer Institute, and colleagues, in The New England Journal of Medicine.

“Pembrolizumab was associated with significantly longer overall survival and with a lower rate of treatment-related adverse events than chemotherapy as second-line therapy for platinum-refractory advanced urothelial carcinoma,” the investigators reported.

Patients were randomized to receive pembrolizumab at 200 mg every 3 weeks (n=266) or investigator’s choice of chemotherapy with paclitaxel (n=84), docetaxel (n=84), or vinflunine (n=87). At a median follow-up of 14.1 months, median overall survival in the total population was 10.3 months in the pembrolizumab group, versus 7.4 months in the chemotherapy group. Among patients with a tumor programmed cell death ligand 1 score of ≥ 10%, median overall survival was 8.0 months in the pembrolizumab group, compared with 5.2 months in the chemotherapy group. No significant difference in progression-free survival was observed.

Grade ≥ 3 treatment-related adverse events occurred more often in the chemotherapy group (49.4% vs. 15.0%).