The following article features coverage from the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Mature data from the KEYNOTE-045 trial ( Identifier: NCT02256436) confirmed the overall survival (OS) benefit of pembrolizumab compared with chemotherapy among patients with recurrent, advanced urothelial carcinoma (UC) with PD-L1 expression.1

Earlier analyses suggested that pembrolizumab prolonged OS compared with chemotherapy in the KEYNOTE-045 trial, with a hazard ratio (HR) of 0.73.

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The open-label, phase 3 KEYNOTE-045 trial randomly assigned 542 patients with UC who progressed after 2 or fewer prior therapies to receive pembrolizumab or investigator’s choice of paclitaxel, docetaxel, or vinflunine. The primary endpoints were OS and progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR) and safety.

The ORR was 21.1% (95% CI, 16.4-26.5%) in the pembrolizumab arm compared with 11.0% (95% CI, 7.6-15.4%) in the chemotherapy arm. The median duration of response was not yet reached (95% CI, 1.6+ to 24.6+ months) with pembrolizumab and was 4.4 months (95% CI, 1.4+ to 24.0+) with chemotherapy.

Pembrolizumab significantly prolonged OS, with a median of 10.3 months compared with 7.4 months with chemotherapy (HR, 0.70; P = .0003) among patients with a combined positive PD-L1 expression score of 10% or greater. The 18-month OS rate was also longer with pembrolizumab at 33.2% (95% CI, 27.5-38.9%) compared with 19.7% (95% CI, 14.7-24.8%) with chemotherapy.

There was no significant difference in median PFS between the pembrolizumab and chemotherapy arms (2.1 vs. 3.3 months; HR, 0.96; P = .32).

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Treatment-related adverse events (AEs) of any grade and grade 3 or higher occurred more frequently with chemotherapy (90.6% and 50.2%, respectively) compared with pembrolizumab (62.0% and 16.5%, respectively).

According to the investigators, these data confirm the survival benefit of pembrolizumab compared with chemotherapy and indicate that OS and duration of response is continuing to improve.

Read more of Cancer Therapy Advisor‘s coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.


  1. de Wit R, Vaughn DJ, Fradet Y, et al. Pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine for recurrent, advanced urothelial cancer (UC): mature results from the phase 3 KEYNOTE-045 trial. Presented at: 2017 ESMO Congress; Madrid, Spain: September 8-12, 2017. Abstract LBA37_PR.